Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
NCT03647488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2022-01-24
Summary
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.
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- DRUG
-
Capmatinib
Capmatinib 400 mg (tablets) orally taken twice daily
- DRUG
-
Spartalizumab
Spartalizumab 400 mg via intravenous infusion once every 28 days
- DRUG
-
Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-26
- Primary Completion
- 2020-09-07
- Completion
- 2020-09-07
- FDA Drug
- Yes
Countries
- United States
- Belgium
- France
- Germany
- Israel
- Spain
Study Locations
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