MET TKI · small molecule
capmatinib
3 active trials across 5 of our biomarkers, targeting MET. 2 active approvals for a biomarker on marked.bio.
Also known as INC280, Tabrecta.
Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.
Approvals and pivotal results
Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.
| Therapy | Biomarker | Tumour | United States | European Union |
|---|---|---|---|---|
capmatinib |
MET exon 14 skipping | NSCLC | Approved 2020 | Approved 2022 |
In the FDA approval summary
GEOMETRY mono-1
single-arm, 60 untreated; 100 previously treated
Trial details and side effects
In the EU summary (EPAR)
GEOMETRY mono-1
single-arm, 100 previously treated Trial details and side effects
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Biomarkers
| Biomarker | Active trials | All trials | Furthest active phase |
|---|---|---|---|
| EGFR exon 19 deletion / L858R | 2 | 11 | Phase 2 |
| MET exon 14 skipping | 1 | 10 | Phase 2/3 |
| ALK fusion | 0 | 1 | – |
| BRAF V600E | 0 | 1 | – |
| ROS1 fusion | 0 | 1 | – |
Sponsors
Industry sponsors leading active biomarker-selected trials of capmatinib.
- Novartis 1
Trials
3 of 21 trials shown
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DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations
capmatinib FDA EU
…sis of a MET-positive malignancy using an analytically next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation).
MET exon 14 skippingSolid Tumour, Haematological Malignancy, Malignant Neoplasm, Neoplasms by Histologic Type
-
Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)
capmatinibosimertinib FDA EUramucirumab FDA EU
Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physicia…
EGFR exon 19 deletion / L858RRecurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
-
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
nazartinibtrametinibribociclibnaporafenibcapmatinibgefitinib FDA EU
…tologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.
EGFR exon 19 deletion / L858REGFR-mutant Non-small Cell Lung Cancer
-
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
capmatinib FDA EU
…GFR wild type (EGFR Negative) and ALK rearrangement negative and who have tested positive MET exon14 skipping mutation (Locally available MET report either by reverse transcriptase polymeras…
MET exon 14 skippingNon-Small Cell Lung Carcinoma
-
Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy
capmatinibosimertinib FDA EUpemetrexedcisplatincarboplatin
…ased Doublet Chemotherapy in Patients With Locally Advanced or Metastatic NSCLC Harboring EGFR Activating Mutations Who Have Progressed on Prior Generation EGFR-TKI Therapy and Whose Tumors Are T790M Muta…
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
capmatinibdocetaxel
… sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations.
EGFR exon 19 deletion / L858RMET exon 14 skippingCarcinoma, Non-Small-Cell Lung
-
Central Nervous System Efficacy of Capmatinib in NSCLC With Brain Metastases With cfDNA Positive MET Alterations
capmatinib FDA EU
Positive for MET amplification or METΔex14 mutation using Predicine's cfDNA assay (PredicineCARE).
MET exon 14 skippingNon-small Cell Lung Cancer
-
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
capmatinib FDA EU
Participant must have MET exon 14 mutation and/or high-level MET amplification (MET: GCN ≥ 10) as determined by a CLIA cert…
MET exon 14 skippingNon-small Cell Lung Cancer
-
Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
… sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations)
EGFR exon 19 deletion / L858RMET exon 14 skippingNon-Small Cell Lung Cancer (NSCLC)
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A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases
capmatinib FDA EU
…ive as assessed by a validated test as part of the participant's standard of care and has MET∆ex14 mutation per Novartis-designated central laboratory or (US only) locally with FoundationO…
MET exon 14 skippingNon-small Cell Lung Carcinoma (NSCLC)
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Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation
capmatinib FDA EU
… histologically or cytologically confirmed, unresectable stage IIIB/IV NSCLC that carries MET exon 14 skipping alteration by molecular testing, as per NGS and RT PCR.
MET exon 14 skippingCancer, Lung Cancer Metastatic, MET Gene Mutation
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A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14 Alterations Who Have Received Prior MET Inhibitor
capmatinib FDA EU
MET exon 14 skipping alteration by molecular testing (local testing is accepted for eligibility
MET exon 14 skippingMalignant Non-small Cell Neoplasm of Lung Stage IV
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Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.
…nts in Phase Ib and Phase II Groups 1 to 4: locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation (or other rare activating mutations that …
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)
EGFR wt status (for exon 19 deletions and exon 21 L858R substitution mutations)
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer
…ticenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients …
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
-
Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma
capmatinibceritinib FDA EUentrectinibregorafenib
Presence of an oncogenic kinase fusion involving ALK, confirmed by assay by a CLIA-approved laboratory
ALK fusionROS1 fusionALK Fusion Protein Expression, BRAF wt Allele, Invasive Skin Melanoma, MET Fusion Gene Positive
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LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
encorafenib FDA EUbinimetinib FDA EUribociclibinfigratinibbuparlisibcapmatinib
Documented evidence of BRAF V600 mutation.
BRAF V600EMelanoma
-
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
capmatinibgefitinib FDA EU
Documented EGFR mutation
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
-
Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation
capmatinib FDA EUtrametinib
Documented MET exon 14 skipping mutation by tumor DNA sequencing or cell-free DNA assay by Clinical Laboratory I…
MET exon 14 skippingMetastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer
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A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification
capmatiniberlotinib FDA EU
EGFR mutation (L858R and /or ex19del)
EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
-
INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer
capmatiniberlotinib FDA EU
G719X, exon 19 deletion, L858R, L861Q)
EGFR exon 19 deletion / L858RRecurrent Non-small Cell Lung Cancer
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