Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

NCT04677595 | Completed Phase 2 Results

• 1 other identifier: CINC280A2204
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

Non small cell lung cancer; Non small cell carcinoma; INC280; capmatinib; NSCLC; MET mutation; MET exon14; EGFTwt; ALK negative; Epidermal growth factor receptor wild type

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) Per RECIST v1.1 by BIRC Assessment

  Tumor response was assessed by a blinded independent review committee (BIRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. The primary efficacy endpoint ORR was estimated and the exact 95% confidence interval (CI) was provided by cohort.

  Up to approximately 125 weeks

Secondary Outcomes (21)

• Duration Of Response (DOR) Per RECIST v1.1 by BIRC Assessment

  Up to approximately 189 weeks (median 33.6 weeks)

• Overall Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment

  Up to approximately 189 weeks (median 33.6 weeks)

• Duration Of Response (DOR) Per RECIST v1.1 by Investigator Assessment

  Up to approximately 189 weeks (median 33.6 weeks)

• Time To Response (TTR) Per RECIST v1.1 by BIRC and Investigator Assessment

  Up to approximately 189 weeks (median 33.6 weeks)

• Disease Control Rate (DCR) Per RECIST v1.1 by BIRC and Investigator Assessment

  Up to approximately 189 weeks (median 33.6 weeks)

Study Arms (2)

Cohort 1

EXPERIMENTAL

Treatment Naive participants

Drug: Capmatinib

Cohort 2

EXPERIMENTAL

Participants received one or two prior lines of treatment

Drug: Capmatinib

Interventions

Capmatinib DRUG

400 mg of capmatinib tablets, administered orally twice daily

Also known as: INC280

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese adult ≥ 18 years old at the time of informed consent
• Histologically confirmed stage IIIB, IIIC or IV NSCLC at the time of study entry, not amenable to curative surgery or radiation or multi-modality therapy (according to staging definition in CSCO guidelines for primary lung cancer, 2019).
• Histologically or cytologically confirmed diagnosis of NSCLC that is:
• EGFR wt: The EGFR wt status assessed as part of standard of care (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations)
• AND ALK rearrangement negative: assessed as part of standard of care by validated test
• AND either:
• Cohort 1: Treatment naive participants with MET mutations, or Cohort 2: Pre-treated participants with MET mutations
• Cohort 1: participants must not have received any systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC). Neo-adjuvant and adjuvant systemic therapies will not count as one prior line of treatment if relapse occurred \> 12 months from the end of the neo-adjuvant or adjuvant systemic therapy.
• Cohort 2: participants must have failed one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC).
• At least one measurable lesion according to RECIST v1.1.
• Adequate organ function
• ECOG performance status (PS) ≤1

You may not qualify if:

• Prior treatment with any MET inhibitor or HGF-targeting therapy.
• Known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
• Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
• Presence or history of interstitial lung disease or interstitial pneumonitis, including, clinically significant radiation pneumonitis affecting activities of daily living or requiring therapeutic intervention.
• Substance abuse, active infection (including active hepatitis B and C, participants whose disease is controlled under antiviral therapy are eligible, and human immunodeficiency virus (HIV) history positive) or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Xiamen, Fujian, 361001, China

Location

Novartis Investigative Site

Foshan, Guangdong, 528000, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510515, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 524000, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150000, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 450003, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430024, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110001, China

Location

Novartis Investigative Site

Jinan, Shandong, 250117, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200030, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Kunming, Yunnan, 650106, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310022, China

Location

Novartis Investigative Site

Beijing, 100142, China

Location

Novartis Investigative Site

Shanghai, 200030, China

Location

Novartis Investigative Site

Tianjin, 300052, China

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 21, 2020
• Study Start: May 17, 2021
• Primary Completion: October 12, 2023
• Study Completion: May 22, 2025
• Last Updated: March 31, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (17)