A phase III, randomized, controlled, open-label, multicenter, global study ofcapmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stageIIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (METÎ?ex14)

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Stage IIIB or IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC (according to Version 8 of the American Joint Committee on Cancer (AJCC) Staging Manual) at the time of study entry.
•2. 3.Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample)
•3. 4.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 candidates for single agent chemotherapy (docetaxel).
•4. At least one measurable lesion as defined by RECIST 1.1
•5. Adequate organ function
•6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

•1. Prior treatment with any MET inhibitor or HGF-targeting therapy.
•2. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (affecting activities of daily living or requiring therapeutic intervention).
•3. Substance abuse, active infection or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation

发起方

ovartis Healthcare Pvt Ltd