Pulmonology & Critical Care
PHASE2
● Phase II
Capmatinib shows efficacy in Chinese NSCLC patients with MET exon 14 skipping mutations
ClinicalTrials.gov
Published March 30, 2026
Novartis Pharmaceuticals
NCT04677595 ↗
This was an open-label, multicenter, two-cohort phase II study designed to evaluate capmatinib in Chinese adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. The study enrolled 36 participants who were EGFR wild-type and ALK rearrangement negative, with advanced (stage IIIB, IIIC, or IV) disease. Cohort 1 consisted of treatment-naive participants, while Cohort 2 included participants who had failed one or two prior lines of therapy in the advanced stage. All participants received capmatinib 400 mg orally twice daily until disease progression or other reasons for discontinuation. The primary outcome measure was overall response rate (ORR) per RECIST v1.1 as assessed by blinded independent review committee (BIRC). The study was conducted from May 17, 2021, to October 12, 2023, with results posted on March 27, 2026. The abstract states the purpose was to learn whether capmatinib, which already shows efficacy and safety in non-Chinese patients, could help Chinese patients control their lung cancer in a safe way. It describes capmatinib as an oral targeted medicine that selectively blocks the effects of the MET gene, which is believed to contribute to cancer progression when dysregulated. The study was sponsored by Novartis Pharmaceuticals. The abstract does not provide specific numerical results for the primary or secondary outcomes, safety data, or detailed efficacy measures beyond the study design and objectives.
Imagine having advanced lung cancer, and doctors find a specific genetic glitch driving it—a mutation in a part of the MET gene called exon 14. This study asked a direct question: could a targeted pill called capmatinib help Chinese patients with this exact situation? The drug works by blocking the faulty MET signal that tells cancer cells to grow. The study enrolled 36 Chinese adults whose cancer had spread (stage IIIB, IIIC, or IV) and who had this MET mutation but not other common mutations like EGFR or ALK. Some patients were new to treatment, while others had tried one or two prior therapies. Everyone took capmatinib pills twice a day. The main goal was to measure how many patients' tumors shrank or disappeared (the overall response rate). The study is now complete, and the results are posted. For patients with this specific genetic driver, the findings could point to a new, targeted way to fight their cancer.
What this means for you: Study tested capmatinib for Chinese patients with advanced lung cancer and a specific MET mutation.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Non-Small Cell Lung Cancer (NSCLC)
Intervention(s): Capmatinib (DRUG)
The purpose of the study was to learn whether the study treatment (capmatinib), which already shows efficacy and safety in non-Chinese patients, could help Chinese patients with controlling their lung cancer in a safe way. Participants had a type of lung cancer called non-small cell lung lancer (NSCLC), with a specific alteration in a part of their DNA (called mutation) of the MET gene, within a specific part of this gene called exon 14.
Participants who had advanced (or metastatic) non-small cell lung cancer with specific mutations in the MET gene but without mutations in the EGFR or ALK genes, who were aged 18 years or older were enrolled in this study.
The study drug, capmatinib (also known as INC280), is an oral drug that is called a 'targeted' medicine, which means it targets particular processes that may not be working properly in cancer cells (called dysregulation). The dysregulation of the MET signaling in cancer cells of patients with NSCLC is believed to make the cancer worse. Capmatinib has been shown to selectively block the effects of the MET gene and therefore may help in keeping the disease under control, stopping cancer cells from growing.
Detailed: This was an open-label, multicenter two-cohort phase II study. Chinese adult participants with EGFR wild-type (wt) (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative, advanced (stage IIIB, IIIC or IV) NSCLC disease harboring MET exon 14-skipping (METΔex14) mutations as determined by a Novartis central molecular laboratory were treated in this study. Cohort 1 included treatment naive participants and Cohort 2 participants who failed one or two prior lines of therapy in the advanced stage (stage IIIB, IIIC or IV). Each participant received 400 mg capmatinib tablet twice daily (BID) until either the disease worsened or there were other reaso
Primary Outcome(s): Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment
Enrollment: 36 (ACTUAL)
Lead Sponsor: Novartis Pharmaceuticals
Start: 2021-05-17 | Primary Completion: 2023-10-12
Results posted: 2026-03-27