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

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.

Key facts

Study ID

NCT03647488

Run by

Novartis Pharmaceuticals

People needed

18

Starts

2018-12-26

Expected to finish

2020-09-07

Last updated by the study team

2022-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
• Subject had 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

You may not qualify if…

• 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 might apply.

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Grenoble, France
• Novartis Investigative Site — Lille Cédex, France
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Tel Aviv, Israel
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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