A phase III randomized, controlled, open-label, multicenter,global study of capmatinib in combination with osimertinibversus platinum - pemetrexed based doublet chemotherapyin patients with locally advanced or metastatic NSCLCharboring EGFR activating mutations who have progressedon prior EGFR-TKI therapy and whose tumors are T790Mmutation negative and harbor MET amplification(GEOMETRY-E)

ovartis Pharma AG0 个研究点目标入组 245 人开始时间: 2022年4月5日最近更新: 2022年5月9日

试验速览

暂无简介。

•1. Signed informed consent must be obtained prior to participation in the study.
•2. Adult = 18 years old at the time of informed consent.
•3. Stage IIIB/IIIC (not amenable to curative surgery, chemoradiation or radiation) or stage IV NSCLC at the time of study entry.
•4. 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 defined as Gene Copy Number (GCN) = 5 per central Novartis designated laboratory
•5. Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (a newly obtained tumor sample, or archival tumor block/slides taken after progression on prior line of EGFR TKI.
•6. Participants must have progressed on one prior line of therapy (either to 1st/2nd generation EGFR TKIs, osimertinib, or other 3rd generation EGFR TKIs used per local standard of care) for advanced/metastatic disease and must be eligible candidates for platinum (cisplatin or carboplatin) - pemetrexed doublet based chemotherapy.
•7. At least one measurable lesion as defined by RECIST 1.1.
•8. ECOG performance status (PS) of 0 or 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 98
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 147

•1. Prior treatment with any MET inhibitor or HGF-targeting therapy.
•2. 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
•3. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
•4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
•5. Treatment with a prior 1st or 2nd generation EGFR TKIs (e.g. erlotinib, gefitinib, afatinib, dacomitinib) osimertinib or another third generation EGFR TKIs such as almonertinib and furmonertinib within 14 days or approximately 5x half-life, whichever is shorter, of the first dose of study treatment
•6. Unable or unwilling to swallow tablets as per dosing schedule

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