Study of efficacy and safety of capmatinib in combination with pembrolizumab versus pembrolizumab alone in subjects with non-small cell lung cancer with PD-L1>= 50%

A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1>= 50%

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225053

Enrollment

Registered

2020-02-06

Start date

2020-01-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non small cell lung cancer (NSCLC)

Interventions

investigational material(s) Generic name etc : INN of investigational material : Capmatinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS >= 50%) ECOG performance status score =< 1 Have at least 1 measurable lesion by RECIST 1.1 Have adequate organ function

Exclusion criteria

Exclusion criteria: Prior treatment with a MET inhibitor or HGF-targeting therapy Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) Have untreated symptomatic central nervous system (CNS) metastases Clinically significant, uncontrolled heart diseases Prior palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1	—

Secondary

Measure	Time frame
- Objective response rate (ORR), Disease control rate (DCR), Time-to-response (TTR), Duration of response (DOR) based on local investigator assessment as per RECIST 1.1 - Overall survival (OS) - Incidence of adverse events is defined as number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose interruption, dose reduction and dose discontinuation. - Pharmacokinetic parameters and concentration - Antidrug antibodies (ADA)	—

Measure

Time frame

- Objective response rate (ORR), Disease control rate (DCR), Time-to-response (TTR), Duration of response (DOR) based on local investigator assessment as per RECIST 1.1 - Overall survival (OS) - Incidence of adverse events is defined as number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose interruption, dose reduction and dose discontinuation. - Pharmacokinetic parameters and concentration - Antidrug antibodies (ADA)

—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Contacts

Public ContactMasataka Yonemura

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026