Lung Cancer Clinical Trial
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
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 first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
The purpose of this study is to evaluate the efficacy and safety of capmatinib in combination with spartalizumab in treatment naive patients with EGFR wild-type, ALK rearrangement negative advanced NSCLC, harboring METΔex14 mutations.
A run-in part (Part 1) will be conducted to determine the anti-tumor activity and safety of capmatinib in combination with spartalizumab. Upon review of safety data and confirmation of anti-tumor activity in Part 1, the randomized part (Part 2) will be initiated to compare the efficacy and safety of capmatinib plus spartalizumab to capmatinib plus placebo.
Combined treatment of METΔex14 mutated NSCLC with capmatinib and spartalizumab is expected to result in improved efficacy compared to each single agent due to direct targeting of an oncogenic driver (MET) as well as more efficient stimulation of an anti-tumor immune response than with PD-1 blockade alone.
The study enrollment was halted on 28-Jul-2021 per sponsor's decision. The enrollment halt decision was based on lack of tolerability observed in capmatinib and spartalizumab combination treatment in the run-in part (Part 1) of the trial.
Following the study enrollment halt during Part 1 (Run in Part), Part 2 will not be initiated.
Immediately following the enrollment halt:
All ongoing subjects were discontinued from spartalizumab treatment and continue to receive single agent capmatinib, given the proven tolerability and efficacy of capmatinib monotherapy in this study indication.
Enrolled subjects who had not started study treatment were to receive capmatinib single agent treatment from the start
Key Inclusion Criteria:
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 Criteria:
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)
Other inclusion and exclusion criteras may apply
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 15 Locations for this study
Boston Massachusetts, 02114, United States
Leuven , 3000, Belgium
Montreal Quebec, H4A 3, Canada
Lille , 59000, France
Paris , 75679, France
Pierre Benite Cedex , 69495, France
Berlin , 13125, Germany
Gerlingen , 70839, Germany
Koeln , 50937, Germany
Tübingen , 72076, Germany
Bologna BO, 40138, Italy
Osaka Sayama Osaka, 589 8, Japan
Seoul , 03080, Korea, Republic of
Barcelona Catalunya, 08036, Spain
Valencia Comunidad Valenciana, 46014, Spain
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.