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

• Status: Active, not recruiting
• Trial end date: 2023-01-13
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Spartalizumab

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