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 and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations

ClinicalTrials.gov Identifier: NCT04323436

Novartis Reference Number: CINC280J12201

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Condition

Carcinoma, Non-Small-Cell Lung

Phase

Phase 2

Overall status

Recruiting

Enrollment count

270 participants

Last update

Oct 14, 2020

Start date

Aug 19, 2020

Completion date

Jan 28, 2032

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

Spartalizumab

Concentrate for solution for infusion

Drug

Capmatinib

Film-coated tablet

Drug

spartalizumab placebo

dextrose 5% in water (D5W) for infusion

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