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

September, 2021

Scientific title

A Phase III Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib in Combination With Osimertinib Versus Platinum - Pemetrexed Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic NSCLC Harboring EGFR Activating Mutations Who Have Progressed on Prior Generation EGFR-TKI Therapy and Whose Tumors Are T790M Mutation Negative and Harbor MET Amplification (GEOMETRY-E)

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.

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.

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Carcinoma, Non-Small-Cell Lung

Other study ID numbers

CINC280L12301; 2020-003677-21

Choose trial site (13)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting