Lung Cancer Clinical Trial

Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations

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 first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

31

Study ID:

NCT04323436

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 15 Locations for this study

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Massachusetts General Hospital Liver and Kidney TX
Boston Massachusetts, 02114, United States
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Montreal Quebec, H4A 3, Canada
Novartis Investigative Site
Lille , 59000, France
Novartis Investigative Site
Paris , 75679, France
Novartis Investigative Site
Pierre Benite Cedex , 69495, France
Novartis Investigative Site
Berlin , 13125, Germany
Novartis Investigative Site
Gerlingen , 70839, Germany
Novartis Investigative Site
Koeln , 50937, Germany
Novartis Investigative Site
Tübingen , 72076, Germany
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Osaka Sayama Osaka, 589 8, Japan
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46014, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

31

Study ID:

NCT04323436

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

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