Study of efficacy and safety of capmatinib in combination with spartalizumab in naive patients with EGFR wild type (wt), ALK rearrangement negative advanced NSCLC, harboring MET exon 14 skipping mutations.

JRCT ID: jRCT2080225343

Registered date:25/08/2020

Basic Information

• Recruitment status: terminated
• Health condition(s) or Problem(s) studied: Non small cell lung cancer(NSCLC)
• Date of first enrollment: 19/08/2020
• Target sample size: 270
• 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 :
Generic name etc :
INN of investigational material : Spartalizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Generic name etc :
INN of investigational material : Spartalizumab placebo (dextrose 5% in water)
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

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

Outcome(s)

Primary Outcome

efficacy
Run-in part:
- Overall Response Rate by Investigator assessment as per RECIST 1.1
Run-in part To evaluate the anti-tumor activity of capmatinib in combination with spartalizumab
Randomized part:
- Progression Free survival (PFS) by BIRC as per RECIST 1.1
Randomized part To compare the efficacy of capmatinib in combination with spartalizumab versus capmatinib plus placebo

Secondary Outcome

Run-in part:
- To assess safety and tolerability of capmatinib in combination with spartalizumab
- AE and SAE, number of patients with dose interruptions, reductions, and dose intensity
- To further evaluate the anti-tumor activity of capmatinib in combination with spartalizumab
- DCR and PFS by investigator asessment
- To evaluate the PK of capmatinib and spartalizumab
- Cmax, Tmax, AUClast, AUCtau

Randomized part:
- To compare overall survival of capmatinib in combination with spartalizumab versus capmatinib plus placebo
- OS
- To assess safety and tolerability of capmatinib in combination with spartalizumab versus capmatinib plus placebo
- AE and SAE, number of patients with dose interruptions, reductions, and dose intensity
- To further evaluate the anti-tumor activity of capmatinib in combination with spartalizumab versus capmatinib plus placebo
- PFS by investigator assessment
- DCR, DOR, ORR, TTR and TTR by BIRC and investigator assessment
- To evaluate patient reported outcomes of capmatinib in combination with spartalizumab versus capmatinib plus placebo
- EORTC QLQ-C30, EQ-LC13, EQ-5D-5L and QLQ-LC13
- To evaluate the PK of capmatinib and spartalizumab
- Cmax, Tmax, AUClast, AUCtau
- To evaluate the prevalence and incidence of immunogenicity of spartalizumab in combination with capmatinib
- prevalence/incidence of 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

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Secondary ID(s): NCT04323436,JapicCTI-205439