A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated participants with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer (NSCLC).

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•Participants are male and female, aged 18 or older (= 20 years of age in Taiwan and Japan).
•--Histologically confirmed locally advanced stage IIIB/IIIC (and not eligible for definitive chemo-radiation curative therapy or complete surgical resection) or stage IV previously treated NSCLC. Presence of a KRAS G12C mutation by central laboratory testing using tissue samples.
•--Participants have received one prior platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy either in combination or in sequence.
•--Participants with ECOG performance status from 0 to 2.

•--Participants who have previously received docetaxel, KRAS G12C inhibitor, or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy.
•--Participants with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) rearrangement by local testing.
•--History of severe hypersensitivity reaction to taxanes or any excipients of these study treatments.

发起方

ovartis Healthcare Pvt Ltd