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| Profile Name | ALK fusion |
| Gene Variant Detail | |
| Relevant Treatment Approaches | ALK Inhibitor |
| Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|---|
| ALK fusion | Erdheim-Chester disease | sensitive | ALK Inhibitor | Ceritinib | Guideline | Actionable | Zykadia (ceritinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring ALK fusions (NCCN.org). | detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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). | 25470694 detail... detail... |
| ALK fusion | Erdheim-Chester disease | sensitive | ALK Inhibitor | Crizotinib | Guideline | Actionable | Xalkori (crizotinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring ALK fusions (NCCN.org). | detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | TQ-B3139 | Phase I | Actionable | In a Phase I trial, TQ-B3139 (CT-711) treatment demonstrated safety and resulted in an overall response rate (ORR) of 61.9% (39/63), an intracranial ORR of 70% (7/10), disease control rate of 84.1% (53/63), and median progression-free survival (PFS) of 19.0 months in patients with non-small cell lung cancer harboring an ALK fusion or ROS1 fusion, with TKI-naive patients demonstrating a longer PFS (25.2 mo vs 5.4 mo, p=0.02) (PMID: 35940055; NCT03099330). | 35940055 |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | Ensartinib | Phase II | Actionable | In a Phase II trial, Ensartinib (X-396) treatment resulted in an objective response in 57% (43/75; all partial responses), and stable disease (SD) in 33% (25/75) of patients with crizotinib-refractory non-small cell lung cancer harboring an ALK fusion, with a response rate of 59% and SD rate of 31% in the 70 patients with EML4-ALK, and a response rate of 40% and SD rate of 60% in the 5 patients with non-EML4 ALK fusions (PMID: 31628085; NCT03215693). | 31628085 |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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 rearrangements (PMID: 28586279; NCT02075840). | detail... 28586279 detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | Alectinib | Phase III | Actionable | In a Phase III trial, treatment with Alecensa (alectinib) resulted in improved progression-free survival compared to treatment with Xalkori (crizotinib) (HR=0.34) in ALK-positive non-small cell lung cancer patients (J Clin Oncol 34, 2016 (suppl; abstr 9008)). | detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | Alectinib | Phase II | Actionable | In a Phase II trial, treatment with Alecensa (alectinib) resulted in a 49% (60/122) overall response rate in non-small cell lung cancer patients positive for an ALK fusion who had previously progressed on Xalkori (crizotinib) therapy (J Clin Oncol 33, 2015 (suppl; abstr 8008)) | detail... |
| ALK fusion | Advanced Solid Tumor | sensitive | ALK Inhibitor | 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 fusion | Advanced Solid Tumor | sensitive | ALK Inhibitor | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival not reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 33.3% (1/3) in patients harboring ALK fusions (PMID: 35395680; NCT02650401). | 35395680 |
| ALK fusion | Advanced Solid Tumor | sensitive | ALK Inhibitor | 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 fusion | Erdheim-Chester disease | sensitive | ALK Inhibitor | Lorlatinib | Guideline | Actionable | Lorbrena (lorlatinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring ALK fusions (NCCN.org). | detail... |
| ALK fusion | inflammatory myofibroblastic tumor | sensitive | ALK Inhibitor | Crizotinib | FDA approved | Actionable | In a Phase I/II trial (Study ADVL0912) that supported FDA approval, Xalkori (crizotinib) therapy was safe and resulted in an objective response rate of 86% (12/14, 5 complete responses, 7 partial responses) and stable disease in 14% (2/14) of pediatric patients with ALK-positive unresectable inflammatory myofibroblastic tumors, with a median duration of response of 1.63 years (PMID: 28787259; NCT00939770). | detail... 28787259 |
| ALK fusion | inflammatory myofibroblastic tumor | sensitive | ALK Inhibitor | Crizotinib | FDA approved | Actionable | In a Phase Ib trial (PROFILE 1013) that supported FDA approval, treatment with Xalkori (crizotinib) resulted in an objective response rate of 66.7% (6/9, 1 complete response, 5 partial responses) and stable disease in 33.3% (3/9) of adult patients with advanced ALK-positive inflammatory myofibroblastic tumors, with a median duration of response of 74.1 weeks in (PMID: 29352732; NCT00939770). | 29352732 detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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 fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | Brigatinib | Phase Ib/II | Actionable | In a phase I/II clinical trial, Alunbrig (brigatinib) was determined to be safe and efficacious in patients with advanced, ALK-fusion positive NSCLC (PMID: 24091716). | 24091716 |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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). | 28475456 detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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). | detail... detail... 25754348 |
| ALK fusion | lung adenocarcinoma | predicted - sensitive | ALK Inhibitor | Lorlatinib | Case Reports/Case Series | Actionable | In a clinical case study, Lorbrena (lorlatinib) treatment resulted in reduction of the brain metastases in a patient with ALK-positive lung adenocarcinoma who had been previously treated with Alecensa (alectinib) and Xalkori (crizotinib) (PMID: 35373538). | 35373538 |
| ALK fusion | anaplastic large cell lymphoma | sensitive | ALK Inhibitor | 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 fusion | lung adenocarcinoma | predicted - sensitive | ALK Inhibitor | Alectinib | Case Reports/Case Series | Actionable | In a clinical case study, Alecensa (alectinib) treatment resulted in shrinkage of the brain and spinal cord metastases in a patient with ALK-positive lung adenocarcinoma, who had been previously treated with Xalkori (crizotinib) (PMID: 35373538). | 35373538 |
| ALK fusion | Erdheim-Chester disease | sensitive | ALK Inhibitor | Alectinib | Guideline | Actionable | Alecensa (alectinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring ALK fusions (NCCN.org). | detail... |
| ALK fusion | Advanced Solid Tumor | predicted - sensitive | ALK Inhibitor | Repotrectinib | Phase I | Actionable | In a Phase I (TRIDENT-1) trial, Repotrectinib (TPX-0005) treatment resulted in stable disease in 25% (4/16) of patient with advanced solid tumor harboring ALK fusions who completed 2 cycles of treatment (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). | detail... |
| ALK fusion | Erdheim-Chester disease | sensitive | ALK Inhibitor | Brigatinib | Guideline | Actionable | Alunbrig (brigatinib) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring ALK fusions (NCCN.org). | detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | Lorlatinib | Phase I | Actionable | In a Phase I trial, Lorlatinib (PF-06463922) demonstrated safety and resulted in a 50% (26/52) overall response rate in patients with ALK-positive or ROS1-positive non-small cell lung cancer, including intracranial responses in patients with CNS metastasis (J Clin Oncol 34, 2016 (suppl; abstr 9009)). | detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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... 30413378 detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | ALK Inhibitor | 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 fusion | lung adenocarcinoma | predicted - sensitive | ALK Inhibitor | Crizotinib | Case Reports/Case Series | Actionable | In a clinical case study, Xalkori (crizotinib) treatment resulted in reduction of the lung tumors in a patient with metastatic ALK-positive lung adenocarcinoma, however, there was development of new brain metastases (PMID: 35373538). | 35373538 |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05397171 | Phase Ib/II | AZD8853 | A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours | Recruiting | USA | FRA | CAN | 1 |
| 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 | |
| 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) | 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 |
| NCT04467801 | Phase II | Ipatasertib Docetaxel + Ipatasertib | Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy | Recruiting | USA | 0 |
| NCT02314481 | Phase II | Vemurafenib Atezolizumab Alectinib Ado-trastuzumab emtansine | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWINII) | Recruiting | 1 | |
| NCT04526782 | Phase II | Docetaxel Binimetinib + Encorafenib | ENCOrafenib With Binimetinib in bRAF NSCLC (ENCO-BRAF) | Recruiting | FRA | 0 |
| NCT04644237 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) | Active, not recruiting | USA | ITA | FRA | ESP | CAN | 5 |
| NCT04116541 | Phase II | Alectinib Cabozantinib Ribociclib + Siremadlin | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (MegaMOST) | Recruiting | FRA | 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 | Recruiting | USA | 0 |
| 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 | ITA | FRA | ESP | DEU | CAN | BEL | 18 |
| NCT04484142 | Phase II | Datopotamab Deruxtecan | Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 5 |
| 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 |
| NCT03107988 | Phase I | Cyclophosphamide + Lorlatinib + Topotecan Lorlatinib | NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) | Recruiting | USA | FRA | CAN | 1 |
| 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 |
| 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 | ITA | ESP | DEU | CAN | BEL | 20 |
| NCT03639714 | Phase Ib/II | GRT-C901 + GRT-R902 + Ipilimumab + Nivolumab | A Study of a Personalized Neoantigen Cancer Vaccine | Active, not recruiting | USA | 1 |
| 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 | Completed | USA | CAN | 0 |
| NCT04895579 | Phase I | Copanlisib + Durvalumab | Lung Cancer With Copanlisib and Durvalumab (LCD) | Recruiting | USA | 0 |
| NCT04862780 | Phase Ib/II | BLU-945 | Study Targeting EGFR Resistance Mechanisms in NSCLC | Recruiting | USA | ESP | 7 |
| 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 | BEL | 10 |
| NCT04211337 | Phase III | Vandetanib Cabozantinib Selpercatinib | A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 14 |
| NCT05435846 | Phase I | Capmatinib + Trametinib | Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation | Recruiting | USA | 0 |
| NCT05501665 | Phase Ib/II | Carboplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Nab-paclitaxel + Pembrolizumab | Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer | Not yet recruiting | USA | 0 |
| NCT05005273 | Phase II | Ipilimumab + Nivolumab BMS-986207 + Ipilimumab + Nivolumab | A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer | Not yet recruiting | USA | ITA | FRA | ESP | DEU | BEL | 7 |
| NCT03915951 | Phase II | Binimetinib + Encorafenib | An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer | Active, not recruiting | USA | ITA | ESP | 2 |
| 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 |
| NCT04294810 | Phase III | Atezolizumab Atezolizumab + Tiragolumab | 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 | ITA | FRA | ESP | DEU | AUT | 19 |
| 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 | ITA | 0 |
| NCT03904108 | Phase II | Ramucirumab | Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy | Terminated | USA | 0 |
| 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 |
| NCT05015010 | Phase II | Alectinib | Alectinib in Neo-adjuvant Treatment of Stage III NSCLC (ALNEO) | Recruiting | ITA | 0 |
| NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf 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 (TAPUR) | Recruiting | USA | 0 |
| NCT04776447 | Phase II | Atezolizumab + Carboplatin + Paclitaxel | Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) | Recruiting | ESP | 0 |
| NCT05077709 | Phase II | IO102-IO103 + Pembrolizumab | IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC | Recruiting | USA | ESP | 1 |
| NCT02949843 | Phase II | Nivolumab + Pembrolizumab | Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations | Terminated | 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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 12 |
| 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 | ITA | FRA | ESP | DEU | 12 |
| 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 | FRA | ESP | DEU | CAN | AUT | 2 |
| 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 | ITA | FRA | ESP | CAN | 3 |
| NCT04940637 | Phase II | Dostarlimab-gxly + Niraparib | UNITO-001-A Phase II Study in HRR/PDL1 Positive MPM/NSCLC | Recruiting | ITA | 0 |
| NCT04268550 | Phase II | Selpercatinib | Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) | Active, not recruiting | USA | 0 |
| NCT03906071 | Phase III | Docetaxel Nivolumab + Sitravatinib | Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
| NCT04513925 | Phase III | Atezolizumab + Tiragolumab 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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 19 |
| NCT03563716 | Phase II | Atezolizumab + Tiragolumab 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 | FRA | ESP | 3 |
| 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 |
| NCT04083976 | Phase II | Erdafitinib | A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 11 |
| NCT03827850 | Phase II | Erdafitinib | FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) | Recruiting | DEU | 0 |
| 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 |
| NCT05014815 | Phase II | BGBA1217 + Tislelizumab Tislelizumab | Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer | Recruiting | USA | FRA | ESP | AUT | 3 |
| 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 | Recruiting | USA | ITA | ESP | CAN | 9 |
| 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 | DEU | 17 |
| 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 |
| 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 |
| 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 | ITA | FRA | ESP | BEL | AUT | 21 |
| 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 |
| 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 |
| 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 |
| NCT04827576 | Phase II | Docetaxel + Hu5F9-G4 | Study of Magrolimab in Participants With Solid Tumors | Recruiting | USA | FRA | ESP | 1 |
| 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 | |
| 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 | ESP | 0 |
| NCT04108026 | Phase II | Durvalumab | Immunotherapy in Patient With Poor General Condition (SAVIMMUNE) | Recruiting | FRA | 0 |
| NCT05364645 | Phase II | Carboplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium + Selpercatinib | Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer | Recruiting | USA | 0 |
| 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 | ITA | FRA | ESP | DEU | BEL | AUT | 8 |
| NCT04612751 | Phase I | Datopotamab Deruxtecan + 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 | FRA | BEL | 1 |
| 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) | Recruiting | USA | 7 |
| NCT04725188 | Phase II | Docetaxel Docetaxel + MK-7684A MK-7684A | Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | BEL | AUT | 13 |
| NCT05061550 | Phase II | Durvalumab + Monalizumab Durvalumab + Oleclumab | Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2) | Recruiting | USA | ITA | FRA | ESP | CAN | 2 |
| 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 |
| 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 | USA | FRA | ESP | BEL | 9 |
| NCT03166631 | Phase I | BI 891065 + Ezabenlimab 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 |
| 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 |
| NCT03965468 | Phase II | Carboplatin + Durvalumab + Paclitaxel | Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC (CHESS) | Active, not recruiting | ESP | 2 |
| NCT03420508 | Phase II | Ensartinib | Treating Patients With Melanoma and ALK Alterations With Ensartinib | Active, not recruiting | USA | 0 |
| 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 | ITA | FRA | ESP | DEU | CAN | 5 |
| NCT05241873 | Phase Ib/II | BLU-451 | Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations | Recruiting | USA | 0 |
| NCT05383001 | Phase II | Cisplatin + Vinorelbine Carboplatin + Vinorelbine Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Carboplatin + Paclitaxel Cisplatin + Paclitaxel Cisplatin + Nab-paclitaxel Durvalumab + Tremelimumab Carboplatin + Nab-paclitaxel Cisplatin + Gemcitabine Carboplatin + Gemcitabine | Randomized Phase II, Open-label Efficacy and Safety Study of Second-line Durvalumab Plus Tremelimumab Versus Platinum-based Chemotherapy Alone in Patients With NSCLC and First-line Checkpoint-inhibitor Therapy (Re-Check) | Withdrawn | DEU | 0 |
| NCT04302025 | Phase II | Cobimetinib + Vemurafenib Entrectinib Atezolizumab Alectinib Pralsetinib | A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer | Recruiting | USA | 0 |
| NCT03066661 | Expanded access | Entrectinib | Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions | No longer available | 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 | FRA | DEU | BEL | 2 |
| NCT03868423 | Phase II | Brigatinib | Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers | Withdrawn | 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 |
| NCT04832854 | Phase II | Atezolizumab + Carboplatin + Pemetrexed Disodium + Tiragolumab Atezolizumab + Carboplatin + Paclitaxel + Tiragolumab Atezolizumab + Tiragolumab Atezolizumab + Cisplatin + Pemetrexed Disodium + Tiragolumab Atezolizumab + Carboplatin + Gemcitabine + Tiragolumab Atezolizumab + Cisplatin + Gemcitabine + Tiragolumab 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 | ESP | 2 |
| 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 |
| 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) | Active, not recruiting | USA | ITA | ESP | DEU | 7 |
| NCT04541407 | Phase I | Osimertinib + Temozolomide Lorlatinib + Temozolomide | Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease | Active, not recruiting | 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) | Recruiting | USA | 1 |
| NCT04656652 | Phase III | Docetaxel Datopotamab Deruxtecan | 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 | ITA | FRA | ESP | DEU | CAN | BEL | 19 |
| NCT04619797 | Phase II | Atezolizumab + Pemetrexed Disodium + Tiragolumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Atezolizumab + Carboplatin + Pemetrexed Disodium + Tiragolumab Atezolizumab + Cisplatin + Pemetrexed Disodium + Tiragolumab | 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 | ITA | FRA | ESP | DEU | CAN | BEL | 6 |
| 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 |
| NCT03391869 | Phase III | Ipilimumab + Nivolumab | Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer | Recruiting | USA | 0 |
| NCT04047862 | Phase I | BGBA1217 + Tislelizumab BGBA1217 + Cisplatin + Pemetrexed Disodium + Tislelizumab BGBA1217 + Carboplatin + Pemetrexed Disodium + Tislelizumab BGBA1217 + Cisplatin + Paclitaxel + Tislelizumab BGBA1217 + Carboplatin + Paclitaxel + Tislelizumab BGBA1217 + Carboplatin + Nab-paclitaxel + Tislelizumab BGBA1217 + Capecitabine + Tislelizumab BGBA1217 + Cisplatin + Etoposide + Tislelizumab BGBA1217 + Cisplatin + Fluorouracil + Tislelizumab BGBA1217 + Carboplatin + Etoposide + Tislelizumab BGBA1217 + Capecitabine + Oxaliplatin + Tislelizumab | Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors | Recruiting | USA | 5 |
| 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 |
| NCT04512430 | Phase II | Atezolizumab + Bevacizumab + Carboplatin + Pemetrexed Disodium | Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients | Recruiting | ESP | 0 |
| NCT04585815 | Phase Ib/II | Axitinib + PF-06801591 + SGN-TGT Binimetinib + Encorafenib + PF-06801591 | A Study of Sasanlimab With Other Therapies in People With Non-small Cell Lung Cancer | Recruiting | USA | CAN | BEL | 3 |
| NCT03993873 | Phase Ib/II | TPX-0022 | Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET | Recruiting | USA | FRA | ESP | 1 |
| NCT05493566 | Phase I | Aldesleukin + Pembrolizumab | Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer | Not yet recruiting | USA | 0 |
| 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 | ITA | FRA | ESP | DEU | CAN | 16 |
| 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 | FRA | ESP | 13 |
| NCT04655976 | Phase II | Docetaxel Cobolimab + Docetaxel + Dostarlimab-gxly Docetaxel + Dostarlimab-gxly | Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants (COSTAR Lung) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | 11 |
| 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) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 7 |
| 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 |
| NCT04758949 | Phase II | Nivolumab FL-101 + Nivolumab FL-101 | FL-101 in Surgically Resectable Non-Small Cell Lung Cancer | Withdrawn | 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) | Terminated | USA | 0 |