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%

JRCT ID: jRCT2080225053

Registered date:06/02/2020

Basic Information

• Recruitment status: terminated
• Health condition(s) or Problem(s) studied: Non small cell lung cancer (NSCLC)
• Date of first enrollment: 22/01/2020
• Target sample size: 96
• Countries of recruitment: Japan,Asia except Japan,North America,Europe,Oceania
• Study type: Interventional

Intervention(s)

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

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

Outcome(s)

• Primary Outcome: Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1

Secondary Outcome

- 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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Secondary ID(s): NCT04139317,JapicCTI-205148