capmatinib
capmatinib: developed by 1 company · 7 clinical trials tracked · 1 FDA decision.
capmatinib evidence translation
What we can confirm
1 FDA record · 7 tracked trials
What it means
What to watch
Prepared research question
How could capmatinib → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| Novartis AG (NVS) | Approved |
Clinical Trials (7)
Managed Access Programs for INC280, Capmatinib
A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
Primary endpoint: Investigator-assessed progression-free survival
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations
Primary endpoint: Number of patients who consent to each arm.
A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Primary endpoint: Phase 1: Number of Participants with Adverse events (AEs) by Severity
A Prospective, Multicenter, Open-label, Phase IV, Interventional Study to Assess the Safety and Efficacy of Capmatinib in Indian Patients With Mesenchymalepithelial Transition (MET) Exon 14 Skipping Mutation Positive Advanced Nonsmall Cell Lung Cancer (NSCLC).
Primary endpoint: Percentage of participants with Adverse Events (AEs)
A Phase II, Multicenter, Two-cohort Study of Oral MET Inhibitor Capmatinib in Chinese Adult Patients With EGFR Wild-type (wt), ALK Rearrangement Negative, MET Exon 14 Skipping Mutations, Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Treatment Naive or Failed One or Two Prior Lines of Systemic Therapy
Primary endpoint: Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment
An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.
Primary endpoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
FDA Decisions1 records
Frequently asked questions
Who is developing capmatinib?
capmatinib is being developed by Novartis AG.
How many clinical trials involve capmatinib?
BioSniper tracks 7 clinical trials involving capmatinib.
What is capmatinib's latest FDA decision?
The most recent tracked FDA decision for capmatinib is Approval for 1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as, dated May 6, 2020.