Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

Status: Active

Description

This is a clinical research study and the purpose of the study is to learn whether the combination of the drugs capmatinib plus spartalizumab helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients with NSCLC. Capmatinib is an oral drug that is called a "targeted" medicine: this means it targets particular processes, which may not be working properly in the cancer cells in your body (called dysregulation) and which may be causing your disease. Spartalizumab is an antibody (a kind of protein that binds to a specific "target" protein). By blocking its "target" protein, called PD-1, spartalizumab may increase the activity of a certain type of cells in your immune system, which may reduce the growth of your tumor. Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy that is being compared with capmatinib and spartalizumab. The reason for this study is to find out which of these two treatments (combination of capmatinib plus spartalizumab OR docetaxel alone) helps to control lung cancer better.

Eligibility Criteria

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.

Locations & Contacts

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Tara Louise Ackerman
Phone: 888-663-3488
Email: Tara.Ackerman@Moffitt.org

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CINC280D2201
Secondary IDs NCI-2019-01029, 2018-001420-19
Clinicaltrials.gov ID NCT03647488