Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-small-cell lung carcinoma, Non-small-cell lung cancer, NSCLC, epidermal growth factor receptor wild type, EGFRwt, Anaplastic lymphoma kinase negative, ALK-, INC280, capmatinib and spartalizumab, combination therapy, docetaxel
Eligibility Criteria
Inclusion Criteria:
- 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
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 might apply.
Sites / Locations
- Highlands Oncology Group
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Run-in part: capmatinib + spartalizumab
Randomized part: capmatinib+spartalizumab
Randomized part: docetaxel
Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
Participants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days
Participants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days