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

Launched by NOVARTIS PHARMACEUTICALS · Mar 24, 2020

Keywords

ClinConnect Summary

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 NSCLC, harboring METΔex14 mutations.

A run-in part (Part 1) was 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) was planned to be initiated to compare the efficacy and safety of capmatinib plus spartalizumab to capmatinib plus plac...

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ALL

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)