Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy
- Trial number:
-
NCT04816214
- Trial phase:
- 3
- Study type:
- Targeted therapy
- Overall status:
- Not yet recruiting
Study start date
Scientific title
Summary
Key
Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, EGFR T790M negative and MET gene amplificationStage 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
Prior treatment with any MET inhibitor or HGF-targeting therapyParticipants 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.