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|Therapy Name||Ceritinib + Ribociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ceritinib||Zykadia||LDK378||ALK Inhibitor 28 ROS1 Inhibitor 19||Zykadia (ceritinib) inhibits ALK, including ALK mutations and fusions, and has additional activity against ROS1 fusions, potentially resulting in decreased tumor cell growth (PMID: 25322323, PMID: 26372962). Zykadia (ceritinib) is FDA approved for ALK-positive (rearrangements and fusions) metastatic non-small cell lung cancer (FDA.gov).|
|Ribociclib||Kisqali||LEE011||CDK4/6 Inhibitor 11||Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|ALK rearrange||lung non-small cell carcinoma||predicted - sensitive||Ceritinib + Ribociclib||Phase Ib/II||Actionable||In a Phase I/II trial, Zykadia (ceritinib) and Kisqali (ribociclib) combination therapy demonstrated a manageable safety profile and resulted in an overall response rate of 37.0% (10/27; 1 complete response and 9 partial responses) with a median progression-free survival of 21.5 months in patients with advanced ALK-rearranged non-small cell lung cancer (PMID: 35298959).||35298959|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02780128||Phase I||Siremadlin Ceritinib + Ribociclib Trametinib||Next Generation Personalized Neuroblastoma Therapy||Recruiting||USA||0|
|NCT02292550||Phase Ib/II||Ceritinib + Ribociclib||Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.||Completed||USA | ITA | FRA | ESP||2|