Status:
TERMINATED
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as...
Detailed Description
The purpose of this study was to evaluate the efficacy and safety of capmatinib in combination with spartalizumab in treatment naive patients with EGFR wild-type, ALK rearrangement negative advanced N...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed locally advanced or metastatic NSCLC which is EGFR wild-type, ALK rearrangement negative and METΔex14 mutated
- No prior systemic therapy for advanced/metastatic disease (neo-adjuvant/adjuvant treatment completed \> 12 months before relapse are permitted)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Measurable disease as per RECIST 1.1
- Known PD-L1 tumor expression status (applicable to Randomized part 2 only)
- Key
Exclusion
- Prior treatment with a PD-1/PD-L1 inhibitor, MET inhibitor or HGF inhibitor
- Presence of symptomatic CNS metastases or requiring local CNS-directed therapy (radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry
- Impaired cardiac function or clinically significant cardiac disease
- Presence or history of interstitial lung disease, non-infectious pneumonitis or interstitial pneumonitis, including clinically significant radiation pneumonitis
- History of allogenic bone marrow or solid organ transplant
- Radiotherapy to lung fields ≤ 4 weeks or to any other anatomic site ≤ 2 weeks prior to start of study treatment (palliative radiotherapy for bone lesions is allowed)
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04323436
Start Date
August 19 2020
End Date
January 26 2023
Last Update
October 9 2024
Active Locations (15)
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1
Massachusetts General Hospital Liver and Kidney TX
Boston, Massachusetts, United States, 02114
2
Novartis Investigative Site
Leuven, Belgium, 3000
3
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
4
Novartis Investigative Site
Lille, France, 59000