Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

Official Title

A Double-blind, Placebo Controlled, Randomized, Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations

Summary:

A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations

Trial Description

Primary Outcome:

  • Overall Response Rate by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
  • Progression Free survival (PFS) by BIRC as per RECIST 1.1
Secondary Outcome:
  • Adverse events (AE) and Serious Adverse events (SAE) incidence
  • Number of patients with dose interruptions, reductions, and dose intensity
  • Efficacy measurements per RECIST 1.1: Overall Response Rate (ORR)
  • Efficacy measurements per RECIST 1.1 : Disease Control Rate (DCR) by BIRC and investigator asessment
  • Efficacy measurements per RECIST 1.1 : Duration of Response (DOR) by BIRC and investigator assessment
  • Efficacy measurements per RECIST 1.1 : Progression Free Survival (PFS) by BIRC and investigator assessment
  • Efficacy measurements per RECIST 1.1: Time to Response (TTR) by BIRC and investigator assessment
  • Overall Survival (OS)
  • Time to definitive 10 points deterioration symptom scores for pain in chest, coughing and dyspnea per QLQ-LC13 questionnaire
  • Change from baseline in EORTC QLQ-C30 questionnaires
  • Change from baseline in QLQ-LC13 questionnaires
  • Change from baseline in EQ-5D-5L questionnaires
  • Pharmacokinetics (PK): Cmax
  • Pharmacokinetics (PK): Tmax
  • Pharmacokinetics (PK): AUClast
  • Pharmacokinetics (PK): AUCtau
  • Antidrug antibody (ADA) prevalence on treatment with spartalizumab
  • Antidrug antibody (ADA) incidence on treatment with spartalizumab
  • Overall survival (OS)
  • Adverse events (AE) and Serious Adverse events (SAE) incidence
  • Number of patients with dose interruptions, reductions, and dose intensity
  • Efficacy measurements per RECIST 1.1: Progression Free Survival (PFS) by investigator assessment
  • Efficacy measurements per RECIST 1.1: Disease Control Rate (DCR) by BIRC and investigator assessment
  • Efficacy measurements per RECIST 1.1: Duration of Response (DOR) by BIRC and investigator assessment
  • Efficacy measurements per RECIST 1.1: Overall Response Rate (ORR) by BIRC and investigator assessment
  • Efficacy measurements per RECIST 1.1: Time to Response (TTR) by BIRC and investigator assessment
  • Change from baseline in EORTC QLQ-C30 questionnaires
  • Change from baseline in EQ-LC13 questionnaires
  • Change from baseline in EQ-5D-5L questionnaires
  • Time to definitive 10 points deterioration symptom scores for pain in chest, coughing and dyspnea per QLQ-LC13 questionnaire
  • Pharmacokinetics (PK): Cmax
  • Pharmacokinetics (PK): Tmax
  • Pharmacokinetics (PK): AUCtau
  • Pharmacokinetics (PK): AUClast.
  • Antidrug antibodies (ADA) prevalence at baseline on treatment with spartalizumab
  • Antidrug antibodies (ADA) incidence on treatment with spartalizumab
The purpose of this study is to evaluate the efficacy and safety of capmatinib in combination with spartalizumab in treatment naive patients with EGFR wild-type, ALK rearrangement negative advanced NSCLC, harboring METΔex14 mutations. A run-in part (Part 1) will be conducted to determine the anti-tumour activity and safety of capmatinib in combination with spartalizumab. Upon review of safety data and confirmation of anti-tumour activity in Part 1, the randomized part (Part 2) will be initiated to compare the efficacy and safety of capmatinib plus spartalizumab to capmatinib plus placebo. Combined treatment of METΔex14 mutated NSCLC with capmatinib and spartalizumab is expected to result in improved efficacy compared to each single agent due to direct targeting of an oncogenic driver (MET) as well as more efficient stimulation of an anti-tumour immune response than with PD-1 blockade alone.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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