Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy

• Status: Recruiting
• Trial end date: 2027-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This phase III study is designed to evaluate the anticancer activity of capmatinib in combination with osimertinib compared to platinum-pemetrexed based doublet chemotherapy as second line treatment in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, T790M negative, mesenchymal-to-epithelial transition factor (MET) amplified who progressed following EGFR tyrosine kinase inhibitors (TKIs). The randomized part will be preceded by a safety run-in part in which the recommended dose of the combination of capmatinib and osimertinib will be confirmed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Carboplatin; Cisplatin; Osimertinib; Pemetrexed

Criteria

Key Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, EGFR T790M negative and MET gene amplification

• Stage IIIB/IIIC NSCLC

• Patients must have progressed on one prior line of therapy (1st/2nd generation EGFR TKIs, osimertinib or other third generation EGFR TKIs) for advanced/metastatic disease (stage IIIB/IIIC and must be candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

• Participants must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1 Common Terminology Criteria Adverse Event 5.0 (CTCAE v 5.0)

• At least one measurable lesion as defined by RECIST 1.1

Key Exclusion Criteria:

• Prior treatment with any MET inhibitor or HGF-targeting therapy

• Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms

• Carcinomatous meningitis

• Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years

• Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis

• Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome

• Clinically significant, uncontrolled heart diseases

• known druggable molecular alterations that may render participants eligible for alternative targeted therapies

Other protocol-defined inclusion/exclusion criteria may apply.