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 1st / 2nd generation EGFR-TKI or osimertinib therapy and whose tumors are T790M mutation negative and harbor MET amplification (GEOMETRY-E)

Suzuki Kazuyuki0 个研究点目标入组 245 人开始时间: 2021年9月16日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations known to be associated with EGFR TKI sensitivity, T790M negative and MET gene amplification
•- Stage IIIB/IIIC NSCLC
•- Patients must have failed maximum one prior line of therapy (either to 1st/2nd generation EGFR TKIs or osimertinib) 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

•- 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

发起方

Suzuki Kazuyuki