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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2032
  • participants needed
    270
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 September 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (6.7 mi away) Contact
+20 other location
systemic therapy
measurable disease
metastasis
EGFR
stage iv non-small cell lung cancer
lung carcinoma

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 (METex14) mutations

Description

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 METex14 mutations.

A run-in part (Part 1) will be conducted to determine the anti-tumor activity and safety of capmatinib in combination with spartalizumab. Upon review of safety data and confirmation of anti-tumor 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 METex14 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-tumor immune response than with PD-1 blockade alone.

Details
Condition Non-Small Cell Lung Cancer
Treatment capmatinib, spartalizumab, spartalizumab placebo
Clinical Study IdentifierNCT04323436
SponsorNovartis Pharmaceuticals
Last Modified on26 September 2021

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