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:
Terminated

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 study aimed 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).

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 or IV NSCLC Participants 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 Participants must have adequate organ function

Key

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Intervention model description: The study was terminated early based on Sponsor's decision unrelated to any safety concerns and the randomized part of the study was not initiated, Masking: None (Open Label),

Conditions

Carcinoma, Non-Small-Cell Lung

Other study ID numbers

CINC280L12301; 2020-003677-21

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