Molecular Profile Detail

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Profile Name ALK fusion
Gene Variant Detail

ALK fusion (unknown)

Relevant Treatment Approaches ALK Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK rearrange lung non-small cell carcinoma no benefit Erlotinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ALK rearrange lung non-squamous non-small cell carcinoma sensitive Ceritinib Phase III Actionable In a Phase III trial, first-line treatment with Zykadia (ceritinib) resulted in an improved median progression-free survival of 16.6 months, compared to 8.1 months with chemotherapy, in patients with ALK-rearranged non-squamous non-small cell lung cancer (PMID: 28126333; NCT01828099). 28126333
ALK rearrange lung non-small cell carcinoma no benefit Osimertinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ALK rearrange inflammatory myofibroblastic tumor sensitive Brigatinib Guideline Actionable Alunbrig (brigatinib) is included in guidelines for inflammatory myofibroblastic tumor patients with ALK translocations (NCCN.org). detail...
ALK rearrange anaplastic large cell lymphoma sensitive Crizotinib FDA approved Actionable In a Phase I/II trial that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate (ORR) of 83% (5/6, all complete responses (CR)) at the 165 mg dose, and an ORR of 90% (18/20, 16 CR) at the 280 mg dose, in pediatric patients 1 years of age or older and young adults with relapsed or refractory ALK-positive anaplastic large cell lymphoma (PMID: 28787259; NCT00939770). 28787259 detail...
ALK rearrange anaplastic large cell lymphoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as second-line and subsequent therapy for patients with anaplastic large cell lymphoma harboring ALK rearrangements (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma no benefit Nivolumab Guideline Actionable Immune checkpoint inhibitors including Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab) are not indicated for use as subsequent therapy in non-small cell lung cancer patients with ALK rearrangement (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma no benefit Nivolumab Clinical Study - Cohort Actionable In a retrospective analysis, PD-1/PD-L1 inhibitors (Opdivo (nivolumab), Keytruda (pembrolizumab), Durvalumab (MEDI4736), or Tecentriq (atezolizumab)) resulted in lower objective response rate (3.6%, 1/28) in non-small cell lung cancer patients harboring EGFR mutations (22/28) or ALK rearrangement (6/28) compared to EGFR wild-type, ALK negative/unknown patients (23.3%, 7/30) (PMID: 27225694). 27225694
ALK rearrange lung non-small cell carcinoma sensitive Ceritinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, Zykadia (ceritinib) resulted in a blinded independent review committee (BIRC)-assessed objective response rate of 44% (72/163) and a duration of response of 7.1 months in ALK-rearranged non-small cell lung cancer patients (PMID: 25754348; NCT01283516). 25754348 detail... detail...
ALK rearrange lung non-small cell carcinoma sensitive Ceritinib Clinical Study - Cohort Actionable In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated a median overall survival of 49.5 months following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Zykadia (ceritinib), and radiotherapy (PMID: 26438117). 26438117
ALK rearrange lung non-small cell carcinoma sensitive Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines as first-line and as subsequent therapy for patients with advanced or metastatic ALK-rearranged non-small cell lung cancer (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Ceritinib Phase II Actionable In a Phase II trial (ASCEND-2), non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement and previously treated with Xalkori (crizotinib) and chemotherapy demonstrated an overall response rate of 38.6% (54/140), a disease control rate of 77.1%, a median time to response of 1.8 months, a median duration of response of 9.7 months, and a median progression-free survival of 5.7 months when treated with Zykadia (ceritinib) (PMID: 27432917; NCT01685060). 27432917
ALK rearrange lung non-small cell carcinoma sensitive Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 32169226; ESMO.org). 32169226 detail...
ALK rearrange lung adenocarcinoma predicted - sensitive Bevacizumab + Lorlatinib Case Reports/Case Series Actionable In a clinical case study, a lung adenocarcinoma patient with brain metastasis harboring an ALK rearrangement, who had progressed on single agent Lorbrena (lorlatinib) treatment, demonstrated a partial response when treated with a combination of Lorbrena (lorlatinib) and Avastin (bevacizumab), with a 68% decrease in tumor size in the brain and a total duration of disease control for 9.1 months (PMID: 33283131). 33283131
ALK rearrange lung non-small cell carcinoma predicted - sensitive PLB1003 Phase I Actionable In a Phase Ia trial, PLB1003 demonstrated safety and preliminary efficacy, resulted in a disease control rate of 86% (12/14, 10 partial response, 2 stable disease) in patients with ALK-rearranged non-small cell lung cancer who progressed on or did not tolerate previous treatment (Journal of Thoracic Oncology, Volume 14, Issue 10, S651). detail...
ALK rearrange inflammatory myofibroblastic tumor sensitive Crizotinib Case Reports/Case Series Actionable In a Phase I/II trial, Xalkori (crizotinib) treatment was well-tolerated and resulted in a partial response in 3 of 7 pediatric patients with ALK-rearranged inflammatory myofibroblastic tumors, and 3 of the 7 patients achieved stable disease (PMID: 23598171; NCT00939770). 23598171
ALK rearrange inflammatory myofibroblastic tumor sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines for inflammatory myofibroblastic tumor patients with ALK translocations (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Lorlatinib Guideline Actionable Lorbrena (lorlatinib) is included in guidelines as preferred first-line therapy and as subsequent therapy for patients with advanced or metastatic ALK-rearranged non-small cell lung cancer (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Lorlatinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial that supported FDA approval, Lorbrena (lorlatinib) treatment resulted in an objective response (OR) rate of 47% (93/198; 4 CR, 89 PR) and a median time to overall first tumor response of 1.4 months, and an objective intracranial response rate of 63% (51/81) and median time to first intracranial response of 1.4 months in ALK-positive (rearrangement or fusion) non-small cell lung cancer patients who had received at least one prior ALK inhibitor therapy (PMID: 30413378; NCT01970865). detail... detail... 30413378
ALK rearrange lung non-small cell carcinoma sensitive Lorlatinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (Study B7461006) that supported FDA approval, Lorbrena (lorlatinib) treatment significantly improved 12-month progression-free survival rate (78% vs 39%, HR 0.28, p<0.001) compared to Xalkori (crizotinib) in patients with advanced ALK-positive non-small cell lung cancer who had no prior systemic therapy, objective response rate was 82% (57/69) with 71% achieved complete intracranial response in patients with brain metastasis (PMID: 33207094; NCT03052608). 33207094 detail... detail...
ALK rearrange lung non-small cell carcinoma sensitive Lorlatinib Guideline Actionable Lorbrena (lorlatinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement who have progressed on an ALK tyrosine kinase inhibitor (PMID: 32169226; ESMO.org). detail... 32169226
ALK rearrange lung non-small cell carcinoma sensitive Lorlatinib Phase I Actionable In a Phase I trial, Lorbrena (lorlatinib) treatment resulted in an objective response in 46% (19/41) of patients with non-small cell lung carcinoma harboring an ALK rearrangement (PMID: 29074098; NCT03052608). 29074098
ALK rearrange lung non-small cell carcinoma no benefit Atezolizumab Clinical Study - Cohort Actionable In a retrospective analysis, PD-1/PD-L1 inhibitors (Opdivo (nivolumab), Keytruda (pembrolizumab), Durvalumab (MEDI4736), or Tecentriq (atezolizumab)) resulted in lower objective response rate (3.6%, 1/28) in non-small cell lung cancer patients harboring EGFR mutations (22/28) or ALK rearrangement (6/28) compared to EGFR wild-type, ALK negative/unknown patients (23.3%, 7/30) (PMID: 27225694). 27225694
ALK rearrange lung non-small cell carcinoma no benefit Atezolizumab Guideline Actionable Immune checkpoint inhibitors including Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab) are not indicated for use as subsequent therapy in non-small cell lung cancer patients with ALK rearrangement (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma no benefit Ipilimumab + Nivolumab Guideline Actionable Immune checkpoint inhibitors including Keytruda (pembrolizumab), Tecentriq (atezolizumab), and the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) are not indicated for use as initial systemic therapy in non-small cell lung cancer patients harboring oncogenes, including ALK rearrangement (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement, or as a next-line therapy in patients with ALK-rearranged non-small cell lung cancer who have not received prior Xalkori (crizotinib) (PMID: 32169226; ESMO.org). 32169226 detail...
ALK rearrange lung non-small cell carcinoma sensitive Crizotinib Phase III Actionable In a Phase III trial (PROFILE 1014), Xalkori (crizotinib) treatment resulted in improved progression-free survival (PFS) (PFS=10.9 months, n=172) relative to chemotherapy (PFS=7.0 months, n=171) in NSCLC patients with ALK rearrangements, including patients with and without brain metastases at baseline, and improved intracranial disease rate in patients with brain metastases at baseline (PMID: 27022118; NCT01154140). 27022118
ALK rearrange lung non-small cell carcinoma sensitive Crizotinib Phase III Actionable In a Phase III trial, Xalkori (crizotinib) treatment resulted in improved objective response (87.5%, 90/103 vs 45.6%, 47/103) and median progression free survival (11.1 vs 6.8 mo) compared to pemetrexed, cisplatin and carboplatinin combination treatment in treatment-naive ALK positive advanced non-small cell lung carcinoma patients (J Clin Oncol 34, 2016 (suppl; abstr 9058); NCT01639001). detail...
ALK rearrange lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROFILE 1014) that supported FDA approval, Xalkori (crizotinib) treatment resulted in improved progression-free survival (10.9 vs 7.0 months, HR=0.45, p<0.001) and objective response rate (74% vs 45%) relative to chemotherapy in NSCLC patients with ALK rearrangements (PMID: 25470694; NCT01154140). detail... 25470694 detail...
ALK rearrange lung non-small cell carcinoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as first-line therapy for ALK rearranged non-small cell lung cancer (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Ceritinib + Crizotinib Clinical Study - Cohort Actionable In a retrospective analysis of patients with ALK-rearrangement positive non-small cell lung cancer, the combined median progression-free survival for sequential treatment with Xalkori (crizotinib) and Zykadia (ceritinib) without intervening treatments was 17.0 months, and overall survival was 49.4 months (PMID: 25724526). 25724526
ALK rearrange lung non-small cell carcinoma no benefit Pembrolizumab Guideline Actionable Immune checkpoint inhibitors including Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab) are not indicated for use as subsequent therapy in non-small cell lung cancer patients with ALK rearrangement (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma no benefit Pembrolizumab Clinical Study - Cohort Actionable In a retrospective analysis, PD-1/PD-L1 inhibitors (Opdivo (nivolumab), Keytruda (pembrolizumab), Durvalumab (MEDI4736), or Tecentriq (atezolizumab)) resulted in lower objective response rate (3.6%, 1/28) in non-small cell lung cancer patients harboring EGFR mutations (22/28) or ALK rearrangement (6/28) compared to EGFR wild-type, ALK negative/unknown patients (23.3%, 7/30) (PMID: 27225694). 27225694
ALK rearrange lung non-small cell carcinoma no benefit Afatinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma no benefit Gefitinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ALK rearrange inflammatory myofibroblastic tumor sensitive Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines for inflammatory myofibroblastic tumor patients with ALK translocations (NCCN.org). detail...
ALK rearrange inflammatory myofibroblastic tumor sensitive Ceritinib Phase I Actionable In a Phase I trial, Zykadia (ceritinib) treatment was well tolerated and resulted in an overall response rate of 70% (7/10; 7 partial responses) and a disease control rate of 80% (8/10) in pediatric patients with inflammatory myofibroblastic tumor harboring ALK rearrangement, with median progression-free survival unreached (PMID: 34780709; NCT01742286). 34780709
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Guideline Actionable Alecensa (alectinib) is included in guidelines as preferred first-line therapy and as subsequent therapy for patients with ALK-rearranged advanced or metastatic non-small cell lung cancer (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Clinical Study - Cohort Actionable In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated prolonged survival following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Alecensa (alectinib), and radiotherapy (PMID: 26438117). 26438117
ALK rearrange lung non-small cell carcinoma sensitive Alectinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial supporting FDA approval (ALEX), Alecensa (alectinib) treatment resulted in improved rate of progression-free survival compared to Xalkori (crizotinib) (68.4% vs 48.7%, HR=0.47), and median progression-free survival (25.7 vs 10.4 months) in non-small cell lung cancer patients harboring ALK rearrangement (PMID: 28586279; NCT02075840). 28586279 detail... detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Phase II Actionable In a Phase II trial, Alecensa (alectinib) treatment was effective in treating non-small cell lung cancer patients with ALK rearrangement, resulting in a 50% (61/122) objective response rate (ORR) in all patients, a 45% (43/96) ORR in Crizotinib-refractory patients, and an 83% (70/84) CNS disease control rate (PMID: 26598747). 26598747
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Guideline Actionable Alecensa (alectinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 32169226; ESMO.org). 32169226 detail...
ALK rearrange anaplastic large cell lymphoma predicted - sensitive Ceritinib Phase I Actionable In a Phase I trial, Zykadia (ceritinib) treatment was well tolerated and resulted in an overall response rate of 75% (6/8; 2 complete responses, 4 partial responses) and a disease control rate of 88% (7/8) in pediatric patients with anaplastic large cell lymphoma harboring ALK rearrangement, with median progression-free survival unreached (PMID: 34780709; NCT01742286). 34780709
ALK rearrange anaplastic large cell lymphoma not applicable N/A Guideline Prognostic The presence of ALK rearrangement is associated with a favorable prognosis in patients with anaplastic large cell lymphoma (NCCN.org). detail...
ALK rearrange anaplastic large cell lymphoma not applicable N/A Guideline Diagnostic ALK rearrangement aids in the diagnosis of anaplastic large cell lymphoma (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib Guideline Actionable Alunbrig (brigatinib) is included in guidelines as preferred first-line and as subsequent therapy for patients with advanced or metastatic ALK-rearranged non-small cell lung cancer (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib FDA approved - Has Companion Diagnostic Actionable In a Phase II trial (ALTA) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in an overall response rate of 45% (51/112) in the 90mg arm and 54% (59/110) in the 180mg arm, and median progression-free survival of 9.2 and 11.0 months respectively, in ALK-rearranged (fusion) non-small cell lung carcinoma patients who progressed on Xalkori (crizotinib) (PMID: 28475456; NCT02094573). detail... 28475456
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in superior progression-free survival (HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in patients with ALK-rearrangement positive metastatic non-small cell lung cancer (Ann Oncol., Apr 2019, 30 (Suppl 2):ii48; NCT02737501). detail... detail... detail...
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib Guideline Actionable Alunbrig (brigatinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 32169226; ESMO.org). 32169226 detail...
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib Phase Ib/II Actionable In a Phase I/II trial, Alunbrig (brigatinib) treatment resulted in an objective response rate of 100% (8/8) in ALK inhibitor-naive, ALK-rearranged non-small cell lung cancer (NSCLC) patients, 72% (51/71) in Xalkori (crizotinib) treated ALK-rearranged NSCLC patients, and 83% (5/6) in ALK-rearranged NSCLC patients with CNS metastases (PMID: 27836716; NCT01449461). 27836716
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib Clinical Study - Cohort Actionable In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated prolonged survival following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Alunbrig (brigatinib), and radiotherapy (PMID: 26438117). 26438117
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib Clinical Study Actionable In a retrospective analysis, Alunbrig (brigatinib) demonstrated limited efficacy, resulting in an objective response rate of 17% (3/18) and stable disease in 50% (9/18) of patients with Alecensa (alectinib) refractory, ALK-positive non-small cell lung cancer, with a median progression-free survival of 4.4 months (PMID: 29935304). 29935304
ALK rearrange malignant pleural mesothelioma no benefit CT-707 Case Reports/Case Series Actionable In a Phase I trial, Conteltinib (CT-707) treatment resulted in disease progression after 1 cycle in a patient with ALK-rearranged malignant pleural mesothelioma (PMID: 32181989). 32181989
ALK rearrange lung non-small cell carcinoma no benefit Crizotinib + Onalespib Phase II Actionable In a Phase II trial, Onalespib (AT13387) and Xalkori (crizotinib) combination treatment did not significantly improve median progression free survival (269 vs 266 days) or objective response rate (55.4%, 38/68 vs 45.3%, 31/68) compared to Xalkori (crizotinib) single treatment in patients with non-small cell lung carcinoma harboring either an ALK mutation or ALK rearrangement (J Clin Oncol 34, 2016 (suppl; abstr 9059); NCT01712217). detail...
ALK rearrange Advanced Solid Tumor sensitive ASP3026 Phase I Actionable In a Phase I trial, ASP3026 treatment resulted in a partial response in 50% (8/16) and stable disease in 44% (7/16) of patients with an advanced solid tumor harboring an ALK rearrangement or ALK F1174L (PMID: 26966027; NCT01284192). 26966027
ALK rearrange Advanced Solid Tumor sensitive Belizatinib Phase Ib/II Actionable In a Phase I trial, Belizatinib (TSR-011) treatment resulted in a response in 100% (3/3) of patients with ALK-rearranged advanced solid tumors when administered at higher doses, and stable disease for 7 months or longer in 56% (5/9) of patients at a lower dose (J Clin Oncol 33, 2015 (suppl; abstr 8063)). detail...
ALK rearrange lung non-small cell carcinoma no benefit Durvalumab Guideline Actionable Immune checkpoint inhibitors including Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab) are not indicated for use as subsequent therapy in non-small cell lung cancer patients with ALK rearrangement (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma no benefit Durvalumab Clinical Study - Cohort Actionable In a retrospective analysis, PD-1/PD-L1 inhibitors (Opdivo (nivolumab), Keytruda (pembrolizumab), Imfinzi (durvalumab), or Tecentriq (atezolizumab)) resulted in lower objective response rate (3.6%, 1/28) in non-small cell lung cancer patients harboring EGFR mutations (22/28) or ALK rearrangement (6/28) compared to EGFR wild-type, ALK negative/unknown patients (23.3%, 7/30) (PMID: 27225694). 27225694
ALK rearrange lung non-small cell carcinoma no benefit Belizatinib Phase I Actionable In a Phase I trial, treatment with Belizatinib (TSR-011) in ALK inhibitor-naive non-small cell lung cancer patients (n=14) harboring either an ALK mutation, ALK amplification, or an ALK rearrangement resulted in a partial response in 6 patients and stable disease in 8 patients, however, it was determined that the drug resulted in limited efficacy and development of the drug was discontinued (PMID: 31217479; NCT02048488). 31217479
ALK rearrange Advanced Solid Tumor sensitive Entrectinib Phase I Actionable In a clinical study, combined analysis of 2 Phase I trials showed Rozlytrek (entrectinib) treatment resulted in an objective response rate of 57% (4/7) in patients with ALK rearranged advanced solid tumors that were treatment-naive, but no response (0/19) in patients who received prior Alk inhibitor treatments (PMID: 28183697). 28183697
ALK rearrange Advanced Solid Tumor sensitive Entrectinib Phase I Actionable In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in objective response in 67% (4/6) of patients with advanced solid tumors harboring rearrangement in ALK gene (AACR Apr 2016, Abstract # CT007). detail...
ALK rearrange lung non-small cell carcinoma sensitive Ensartinib Phase III Actionable In a Phase III trial, Ensartinib (X-396) treatment significantly improved progression-free survival in patients with ALK-positive non-small cell lung cancer (25.8 vs 12.7 mo, HR 0.51, p<0.001) compared to Xalkori (crizotinib), and resulted in an intracranial response rate of 63.6% (7 of 11) in patients with target brain metastases at baselinewith compared to 21.1% (4 of 19) with Xalkori (crizotinib) (PMID: 34473194; NCT02767804). 34473194
ALK rearrange lung non-small cell carcinoma sensitive Ensartinib Clinical Study - Cohort Actionable In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated prolonged survival following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Ensartinib (X-396), and radiotherapy (PMID: 26438117). 26438117
ALK rearrange lung non-small cell carcinoma sensitive Ensartinib Phase Ib/II Actionable In a Phase I/II trial, Ensartinib (X-396) treatment resulted in partial response in 60% (36/60) and stable disease in 21.7 % (13/60) of patients with ALK-positive non-small cell lung cancer, with a median progression-free survival of 9.2 months, and a response rate of 80% (12/15) in crizotinib-naïve patients and 69% (20/29) in patients with prior crizotinib treatment (PMID: 29563138; NCT01625234). 29563138
ALK rearrange lung non-small cell carcinoma sensitive Ensartinib Guideline Actionable Ensartinib (X-396) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 32169226, Version Update 15 Sept 2020; ESMO.org). 32169226 detail...
ALK rearrange lung adenocarcinoma predicted - sensitive CT-707 Phase I Actionable In a Phase I trial, Conteltinib (CT-707) demonstrated safety and preliminary efficacy, resulting in an overall response rate of 77% (10/13, 1 complete response, 9 partial responses) and a disease control rate of 85% (11/13) in patients with ALK-rearranged lung adenocarcinoma (n=12) or malignant pleural mesothelioma (n=1), median progression-free survival was 13 months in patients with lung adenocarcinoma (PMID: 32181989). 32181989
ALK mutant lung non-small cell carcinoma no benefit Belizatinib Phase I Actionable In a Phase I trial, treatment with Belizatinib (TSR-011) in ALK inhibitor-naive non-small cell lung cancer patients (n=14) harboring either an ALK mutation, ALK amplification, or an ALK rearrangement resulted in a partial response in 6 patients and stable disease in 8 patients, however, it was determined that the drug resulted in limited efficacy and development of the drug was discontinued (PMID: 31217479; NCT02048488). 31217479
ALK mutant lung non-small cell carcinoma no benefit Crizotinib + Onalespib Phase II Actionable In a Phase II trial, Onalespib (AT13387) and Xalkori (crizotinib) combination treatment did not significantly improve median progression free survival (269 vs 266 days) or objective response rate (55.4%, 38/68 vs 45.3%, 31/68) compared to Xalkori (crizotinib) single treatment in patients with non-small cell lung carcinoma harboring either an ALK mutation or ALK rearrangement (J Clin Oncol 34, 2016 (suppl; abstr 9059); NCT01712217). detail...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04619797 Phase II Atezolizumab + MTIG7192A + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Atezolizumab + Carboplatin + MTIG7192A + Pemetrexed Disodium Atezolizumab + Cisplatin + MTIG7192A + Pemetrexed Disodium A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer Recruiting USA | CAN 11
NCT02154490 Phase II Docetaxel Nivolumab Palbociclib Durvalumab Ipilimumab + Nivolumab AZD4547 Taselisib Durvalumab + Tremelimumab Erlotinib + Rilotumumab Talazoparib Erlotinib Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer Active, not recruiting USA | CAN 0
NCT04526782 Phase II Docetaxel Binimetinib + Encorafenib ENCOrafenib With Binimetinib in bRAF NSCLC (ENCO-BRAF) Recruiting 1
NCT04589845 Phase II Alectinib Ado-trastuzumab emtansine Ipatasertib GDC-0077 Entrectinib Atezolizumab Idasanutlin Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Recruiting USA | CAN 21
NCT05170204 Phase III Durvalumab Alectinib Pralsetinib Entrectinib A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) Not yet recruiting USA 9
NCT04856176 Phase II Carboplatin + Paclitaxel + Pembrolizumab + Sargramostim Carboplatin + Paclitaxel + Pembrolizumab + Pemetrexed Disodium + Sargramostim A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advanced Non-small Cell Lung Cancer Recruiting USA 0
NCT03563716 Phase II Atezolizumab + MTIG7192A Atezolizumab A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Active, not recruiting USA 5
NCT04827576 Phase II Docetaxel + Hu5F9-G4 Study of Magrolimab in Participants With Solid Tumors Recruiting USA 0
NCT04094610 Phase Ib/II Repotrectinib A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Recruiting USA | CAN 4
NCT03107988 Phase I Cyclophosphamide + Lorlatinib + Topotecan Lorlatinib NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) Recruiting USA | CAN 2
NCT03255083 Phase I DS-1205c + Osimertinib DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Terminated 1
NCT03965468 Phase II Carboplatin + Durvalumab + Paclitaxel Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC (CHESS) Recruiting 3
NCT04585815 Phase Ib/II Binimetinib + Encorafenib + PF-06801591 Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer Recruiting USA | CAN 2
NCT04800822 Phase I PF-07284892 Cetuximab + Encorafenib + PF-07284892 Lorlatinib + PF-07284892 Binimetinib + PF-07284892 PF-07284892 in Participants With Advanced Solid Tumors Recruiting USA 0
NCT04995523 Phase Ib/II AZD2936 A Study to Assess the Safety and Efficacy of AZD2936 in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (ARTEMIDE-01) Recruiting 6
NCT04776447 Phase II Atezolizumab + Carboplatin + Paclitaxel Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) Recruiting 1
NCT05006794 Phase I GS-9716 + Sacituzumab govitecan-hziy GS-9716 Docetaxel + GS-9716 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies Recruiting USA 0
NCT04116541 Phase II Alectinib Cabozantinib HDM201 + Ribociclib A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (MegaMOST) Recruiting 1
NCT03993873 Phase I TPX-0022 Phase 1 Study of TPX-0022, a MET/CSF1R/SRC Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in MET Recruiting USA 3
NCT00939770 Phase Ib/II Crizotinib Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma Completed USA | CAN 0
NCT04512430 Phase II Atezolizumab + Bevacizumab + Carboplatin + Pemetrexed Disodium Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients Recruiting 1
NCT03755102 Phase I Dacomitinib A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib. Recruiting USA 0
NCT03213652 Phase II Ensartinib Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) Recruiting USA 1
NCT03906071 Phase III Docetaxel MGCD516 + Nivolumab Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE) Recruiting USA | CAN 10
NCT04892953 Phase II Carboplatin + Durvalumab + Paclitaxel Carboplatin + Durvalumab + Nab-paclitaxel Carboplatin + Durvalumab + Gemcitabine Durvalumab Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy Not yet recruiting USA 0
NCT04612751 Phase I DS-1062a + Durvalumab Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab With or Without Carboplatin in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04) Recruiting USA 2
NCT03066661 Expanded access Entrectinib Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions No longer available USA 0
NCT05012254 Phase II Ipilimumab + Nivolumab Carboplatin + Ipilimumab + Nivolumab + Paclitaxel Cisplatin + Ipilimumab + Nivolumab + Pemetrexed Disodium Carboplatin + Ipilimumab + Nivolumab + Pemetrexed Disodium Study of Nivolumab and Ipilimumab Plus Chemotherapy as a Treatment for Patients With Stage IV Lung Cancer With Brain Metastases (NIVIPI-Brain) Recruiting 1
NCT04929041 Phase II Pembrolizumab Nab-paclitaxel Ipilimumab Paclitaxel Nivolumab Pemetrexed Disodium Carboplatin Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Recruiting USA 0
NCT05004116 Phase Ib/II Irinotecan + Repotrectinib + Temozolomide A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer Recruiting USA 0
NCT03868423 Phase II Brigatinib Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Unknown status USA 0
NCT04591431 Phase II Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) Recruiting 1
NCT04862780 Phase Ib/II BLU-945 Study Targeting EGFR Resistance Mechanisms in NSCLC Recruiting USA 3
NCT03191786 Phase III Atezolizumab Gemcitabine Vinorelbine A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naive Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy (IPSOS) Active, not recruiting CAN 24
NCT05014815 Phase II BGBA1217 + Tislelizumab Tislelizumab Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer Recruiting USA 2
NCT02097810 Phase I Entrectinib Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. (STARTRK-1) Completed USA 1
NCT04047862 Phase I BGBA1217 + Tislelizumab BGBA1217 + Cisplatin + Pemetrexed Disodium + Tislelizumab BGBA1217 + Carboplatin + Pemetrexed Disodium + Tislelizumab BGBA1217 + Carboplatin + Paclitaxel + Tislelizumab BGBA1217 + Carboplatin + Nab-paclitaxel + Tislelizumab BGBA1217 + Cisplatin + Etoposide + Tislelizumab BGBA1217 + Carboplatin + Etoposide + Tislelizumab Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors Recruiting USA 5
NCT03391869 Phase III Ipilimumab + Nivolumab Phase III Trial of (LCT) After Nivolumab and Ipilimumab Recruiting USA 0
NCT04940637 Phase II Dostarlimab-gxly + Niraparib UNITO-001-A Phase II Study Niraparib Plus Dostarlimab in HRR/PDL1 Positive MPM/NSCLC (UNITO-001) Recruiting 1
NCT02949843 Phase II Nivolumab + Pembrolizumab Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations Terminated USA 0
NCT03166631 Phase I BI 754091 + BI 891065 BI 891065 A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Terminated USA 0
NCT05171777 Phase II Atezolizumab A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer Not yet recruiting USA 4
NCT04268550 Phase II Selpercatinib Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) Recruiting USA 0
NCT04863248 Phase II Docetaxel + Trilaciclib Docetaxel Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4) Active, not recruiting USA 0
NCT02134886 Phase I Erlotinib Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection Terminated USA 0
NCT04923126 Phase Ib/II PD-0325901 SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Recruiting USA 0
NCT03164616 Phase III Durvalumab + Tremelimumab Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Cisplatin + Gemcitabine Carboplatin + Gemcitabine Durvalumab Carboplatin + Nab-paclitaxel Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). Recruiting USA 18
NCT03827850 Phase II Erdafitinib FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) Recruiting 1
NCT04302025 Phase II Cobimetinib + Vemurafenib Entrectinib Alectinib Pralsetinib A Study of Alectinib, Entrectinib, Vemurafenib Plus Cobimetinib, or Pralsetinib in Patients With Resectable Stages II-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, BRAF V600, or RET Molecular Alterations Recruiting USA 0
NCT04956692 Phase III Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86) Recruiting USA 10
NCT05153408 Phase Ib/II BLU-701 BLU-701 + Osimertinib BLU-701 + Carboplatin + Pemetrexed Disodium (HARMONY) Study of BLU-701 in EGFR-mutant NSCLC Recruiting USA 0
NCT05064280 Phase II Lenvatinib Pembrolizumab Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases Not yet recruiting USA 0
NCT04083976 Phase II Erdafitinib A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Recruiting USA 14
NCT04294810 Phase III Atezolizumab Atezolizumab + MTIG7192A A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (SKYSCRAPER-01) Recruiting USA 24
NCT04467801 Phase II Ipatasertib Docetaxel + Ipatasertib Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy Recruiting USA 0
NCT03057106 Phase II Cisplatin Gemcitabine Carboplatin Durvalumab + Tremelimumab Pemetrexed Disodium Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC Active, not recruiting CAN 1
NCT04832854 Phase II Atezolizumab + Carboplatin + MTIG7192A + Pemetrexed Disodium Atezolizumab + Carboplatin + MTIG7192A + Paclitaxel Atezolizumab + MTIG7192A Atezolizumab + Cisplatin + MTIG7192A + Pemetrexed Disodium Atezolizumab + Carboplatin + Gemcitabine + MTIG7192A Atezolizumab + Cisplatin + Gemcitabine + MTIG7192A Cisplatin + Gemcitabine Carboplatin + Gemcitabine Carboplatin + Paclitaxel Carboplatin + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer Recruiting USA 2
NCT04267237 Phase II Atezolizumab + RO7198457 Atezolizumab A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer Withdrawn 0
NCT04644237 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) Recruiting USA | CAN 8
NCT04895579 Phase I Copanlisib + Durvalumab Lung Cancer With Copanlisib and Durvalumab (LCD) Recruiting USA 0
NCT04513925 Phase III Atezolizumab + MTIG7192A Durvalumab A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) (SKYSCRAPER-03) Recruiting USA | CAN 25
NCT04211337 Phase III Vandetanib Cabozantinib Selpercatinib A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) Recruiting USA | CAN 19
NCT04774718 Phase Ib/II Alectinib A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors Recruiting USA 6
NCT04541407 Phase I Osimertinib + Temozolomide Lorlatinib + Temozolomide Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease Recruiting USA 0
NCT04644315 Phase II Alectinib A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors (ALpha-T) Recruiting USA 0
NCT05061550 Phase II Durvalumab + Monalizumab Durvalumab + Oleclumab Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2) Not yet recruiting USA 1
NCT03420508 Phase II Ensartinib Treating Patients With Melanoma and ALK Alterations With Ensartinib Active, not recruiting USA 0
NCT03970746 Phase Ib/II PDC*lung01 + Pembrolizumab PDC*lung01 + Pemetrexed Disodium PDC*lung01 Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC Recruiting 5
NCT03639714 Phase Ib/II GRT-C901 + GRT-R902 + Ipilimumab + Nivolumab A Study of a Personalized Neoantigen Cancer Vaccine Active, not recruiting USA 1
NCT03904108 Phase II Ramucirumab Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy Recruiting USA 0
NCT04108026 Phase II Durvalumab Immunotherapy in Patient With Poor General Condition (SAVIMMUNE) Recruiting 1
NCT04471428 Phase III Docetaxel Atezolizumab + Cabozantinib Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy (CONTACT-01) Active, not recruiting USA 14
NCT04581824 Phase II Carboplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Dostarlimab-gxly + Pemetrexed Disodium Carboplatin + Dostarlimab-gxly + Pemetrexed Disodium Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Recruiting USA 10
NCT05117242 Phase II GEN1046 + Pembrolizumab GEN1046 Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Another Anti-cancer Therapy for Treatment of Recurrent (Non-small Cell) Lung Cancer Recruiting 2
NCT02657434 Phase III Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Atezolizumab + Carboplatin + Pemetrexed Disodium Atezolizumab + Cisplatin + Pemetrexed Disodium A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132) Active, not recruiting USA 26
NCT04746924 Phase III Tislelizumab BGBA1217 + Tislelizumab Pembrolizumab A Study of BGB-A1217 With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer Recruiting USA 12
NCT02587650 Phase II Ceritinib Capmatinib Regorafenib Entrectinib Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma Terminated USA 0
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Suspended USA 1
NCT04984811 Phase II Atezolizumab + NT-I7 NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC Recruiting USA 0
NCT05048797 Phase III Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Trastuzumab deruxtecan A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations Recruiting USA | CAN 18
NCT03775486 Phase II Durvalumab + Olaparib Cisplatin + Durvalumab + Pemetrexed Disodium Durvalumab Carboplatin + Durvalumab + Gemcitabine Carboplatin + Durvalumab + Pemetrexed Disodium Carboplatin + Durvalumab + Nab-paclitaxel Cisplatin + Durvalumab + Gemcitabine Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) Active, not recruiting USA 11
NCT04655976 Phase II Docetaxel Docetaxel + Dostarlimab-gxly + TSR-022 Docetaxel + Dostarlimab-gxly Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants (COSTAR Lung) Recruiting USA | CAN 11
NCT04656652 Phase III Docetaxel DS-1062a Study of DS-1062A Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01) Recruiting USA | CAN 23
NCT04758949 Phase II Nivolumab FL-101 + Nivolumab FL-101 FL-101 in Surgically Resectable Non-Small Cell Lung Cancer Withdrawn 0
NCT03999710 Phase II Durvalumab Determining Whether Durvalumab in Combination With Radiation Therapy Can Prevent the Progression of Non-Small Cell Lung Cancer Recruiting USA 0
NCT05015010 Phase II Alectinib Alectinib in Neo-adjuvant Treatment of Stage III NSCLC (ALNEO) Recruiting 1
NCT03334617 Phase II AZD9150 + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan Ceralasertib + Durvalumab Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON) Recruiting USA | CAN 6
NCT02650401 Phase I Entrectinib Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (STARTRK-NG) Recruiting USA | CAN 9
NCT04484142 Phase II DS-1062a Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) Recruiting USA 9
NCT03037385 Phase Ib/II Pralsetinib Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW) Recruiting USA 12
NCT04725188 Phase II Docetaxel Docetaxel + MK-7684A MK-7684A Vibostolimab (+) Pembrolizumab Coformulation (MK-7684A) or Vibostolimab (+) Pembrolizumab Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002) Recruiting USA 18
NCT00932451 Phase II Crizotinib An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Completed USA | CAN 20
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting USA 0
NCT03915951 Phase II Binimetinib + Encorafenib An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer Recruiting USA 4
NCT04005144 Phase I Binimetinib + Brigatinib Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer Recruiting USA 0