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Clinical Trial 19757

Cancer Type: Thoracic
Interventions:Capmatinib; INC280 (Capmatinib); PDR001 (Spartalizumab); Spartalizumab; Taxotere (docetaxel); docetaxel

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Jhanelle Gray

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase II, Multicenter, Randomized, Two-Arm Study Of Capmatinib (INC280, An Oral MET Inhibitor) And Spartalizumab (PDR001, A PD-1 Inhibitor) Combination Therapy Versus Docetaxel In Pretreated Adult Patients With EGFR Wild-Type, ALK Rearrangement Negative Locally Advanced/Metastatic Non-Small Cell Lung Cancer

Summary

Objective

Part 1: Run-in To assess the safety and tolerability of the capmatinib and spartalizumab combination. Part 2: Randomized To assess the overall survival of the combination of capmatinib and spartalizumab in comparison to docetaxel Part 2 Randomized part: To assess objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), duration of response (DOR) and time to response (TTR) based on RECIST 1.1 (Response Evaluation Criteria in Solid Tumors). To assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

Inclusion Criteria

  • Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
  • Subject has demonstrated progression following one prior platinum doublet and one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
  • Subjects must be candidates for single agent docetaxel
  • Subjects must have at least one lesion evaluable by RECIST 1.1

  • Exclusion Criteria

  • Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting therapy
  • Any untreated central nervous system (CNS) lesion
  • Use of any live vaccines against infectious diseases within 12 weeks of initiation of study treatment.
  • Other protocol-defined inclusion/exclusion criteria may apply.