Clinical Trials

Numerous clinical trials evaluate capmatinib across various oncological indications, focusing predominantly on non-small cell lung cancer (NSCLC) with MET alterations such as MET exon 14 skipping mutations, advanced hepatocellular carcinoma, triple-negative breast cancer, and solid tumors. Encompassing Phase 1 through Phase 4 studies, recruitment statuses range from active and recruiting to completed or terminated. These investigations are sponsored by major pharmaceutical entities including Novartis Pharmaceuticals, alongside academic medical centers, health institutions, and international research organizations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02813135 RECRUITING
Pediatric Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2016-08-03 PHASE1; PHASE2
NCT05722886 RECRUITING
Haematological Malignancy; Solid Tumour
Cancer Research UK
 2023-03-01 PHASE2; PHASE3
NCT06988475 RECRUITING
Solid Tumour; Haematological Malignancy; Malignant Neoplasm; Neoplasms by Histologic Type; Neoplasms by Site; Cancer; Malignancy; Glioma; Neuroblastoma; Gastric Cancer; Soft Tissue Sarcoma
Cancer Research UK
 2024-11-19 PHASE2; PHASE3
NCT03040973 ACTIVE_NOT_RECRUITING
Advanced Solid Tumors Which Are cMET-dependent
Novartis Pharmaceuticals
 2017-08-23 PHASE2
NCT05642572 RECRUITING
Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8
SWOG Cancer Research Network
 2023-05-05 PHASE2
NCT05488314 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2022-12-13 PHASE1; PHASE2
NCT05567055 WITHDRAWN
Non-small Cell Lung Cancer
Timothy Burns, MD, PHD
 2023-10-03 PHASE2
NCT05110196 COMPLETED
Non-Small Cell Lung Carcinoma
Novartis Pharmaceuticals
 2022-09-03 PHASE4
NCT06054191 NOT_YET_RECRUITING
NSCLC; BRAF V600 Mutation; MET Exon 14 Mutation
Sun Yat-sen University
 2024-02-01 PHASE2
NCT05243641 TERMINATED
Metastatic Breast Cancer; Breast Cancer
M.D. Anderson Cancer Center
 2022-08-18 PHASE1; PHASE2
NCT04926831 TERMINATED
Non-small Cell Lung Cancer
Novartis Pharmaceuticals
 2022-08-10 PHASE2
NCT03784014 COMPLETED
Soft Tissue Sarcoma
Institut National de la Santé Et de la Recherche Médicale, France
 2019-10-19 PHASE3
NCT05435846 TERMINATED
Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer
Collin Blakely
 2022-08-10 PHASE1
NCT04460729 WITHDRAWN
Non-small Cell Lung Carcinoma (NSCLC)
Novartis Pharmaceuticals
 2020-11-11 PHASE2
NCT04677595 COMPLETED
Non-Small Cell Lung Cancer (NSCLC)
Novartis Pharmaceuticals
 2021-05-17 PHASE2
NCT02414139 COMPLETED
Carcinoma, Non-Small-Cell Lung
Novartis Pharmaceuticals
 2015-06-11 PHASE2
NCT05135845 SUSPENDED
Oesophageal Adenocarcinoma; Gastric Adenocarcinoma
Assistance Publique - Hôpitaux de Paris
 2022-03-22 PHASE2
NCT04427072 TERMINATED
Carcinoma, Non-Small-Cell Lung
Novartis Pharmaceuticals
 2020-09-25 PHASE3
NCT03742349 TERMINATED
Triple Negative Breast Cancer (TNBC)
Novartis Pharmaceuticals
 2019-01-31 PHASE1
NCT04816214 TERMINATED
Carcinoma, Non-Small-Cell Lung
Novartis Pharmaceuticals
 2021-09-22 PHASE3
NCT04323436 TERMINATED
Carcinoma, Non-Small-Cell Lung
Novartis Pharmaceuticals
 2020-08-19 PHASE2
NCT04139317 TERMINATED
Non-small Cell Lung Cancer (NSCLC)
Novartis Pharmaceuticals
 2020-01-22 PHASE2
NCT02795429 COMPLETED
Advanced Hepatocellular Carcinoma
Novartis Pharmaceuticals
 2016-06-15 PHASE1; PHASE2
NCT02750215 COMPLETED
Malignant Non-small Cell Neoplasm of Lung Stage IV
Massachusetts General Hospital
 2016-05 PHASE2
NCT02335944 TERMINATED
Non Small Cell Lung Cancer
Novartis Pharmaceuticals
 2015-01-13 PHASE1; PHASE2
NCT03647488 COMPLETED
Carcinoma, Non-Small-Cell Lung
Novartis Pharmaceuticals
 2018-12-26 PHASE2
NCT03693339 UNKNOWN
Cancer; Lung Cancer Metastatic; MET Gene Mutation
Asan Medical Center
 2018-10-30 PHASE2
NCT02587650 TERMINATED
ALK Fusion Protein Expression; BRAF wt Allele; Invasive Skin Melanoma; MET Fusion Gene Positive; NRAS wt Allele; NTRK1 Fusion Positive; NTRK2 Fusion Positive; NTRK3 Fusion Positive; RET Fusion Positive; ROS1 Fusion Positive; Stage III Cutaneous Melanoma; Stage IIIA Cutaneous Melanoma; Stage IIIB Cutaneous Melanoma; Stage IIIC Cutaneous Melanoma; Stage IV Cutaneous Melanoma
University of California, San Francisco
 2015-03-26 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-10)

Check the Capmatinib (INC280) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Capmatinib functions as a highly selective, ATP-competitive inhibitor of c-MET kinase that binds to the ATP-binding pocket to prevent receptor autophosphorylation and downstream activation of Wnt/β-catenin and epithelial-mesenchymal transition signaling pathways. This potent biochemical inhibition blocks cellular proliferation and migration while inducing apoptosis, ultimately driving tumor regression in c-MET-dependent malignancies such as non-small cell lung cancer harboring MET exon 14 mutations.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.