A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stage IIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (MET*ex14) - CINC280A2301 - capmatinib in EGFR-wild, ALK-neg, MET exon14skip NSCLC

ovartis0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

研究概览

暂无简介。

•* Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality
•therapy) or IV NSCLC at the time of study entry.
•* Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR wt
•(for EGFR mutations that predict sensitivity to EGFR therapy, including, but
•not limited to exon 19 deletions and exon 21 L858R substitution mutations), ALK
•rearrangement negative as assessed by a validated test as part of the
•participant*s standard of care and has MET*ex14 mutation determined by
•Novartis-designated central laboratory or by a locally performed, tissue-based
•test, validated according to local regulation.
•* At least one measurable lesion as defined by RECIST 1.1.
•* Participants must have progressed on one or two prior lines of systemic
•therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for
•surgery, radiation or multi modality therapy] or IV NSCLC) and must be
•docetaxel naive and be candidates for single agent chemotherapy (docetaxel).
•Participants must have progressed on or after the last therapy before study
•* ECOG performance status of 0 or 1.

•* Prior treatment with any MET inhibitor or HGF-targeting therapy
•* Participants with known druggable molecular alterations (such as ROS1 and RET
•rearrangements, BRAF mutation, KRAS mutation, NTRK fusions, etc.) which might
•be a candidate for alternative targeted therapies.
•* 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).
•* Long QT syndrome, family history of idiopathic sudden death or congenital
•long QT syndrome.
•* Clinically significant, uncontrolled heart diseases

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