Study of efficacy and safety of JDQ443 in comparison with docetaxel in participants with non-small cell lung cancer.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2023/03/050253
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) per Blinded Independent Review Committee (BIRC) according to RECIST 1.1Timepoint: Every 6 weeks counting from C1D1 up to 54 weeks and every 12 weeks thereafter until disease progression (by RECIST 1.1) is confirmed by BIRC
- Secondary Outcome Measures
Name Time Method To assess the anti-tumor activity of JDQ443 compared to docetaxelTimepoint: Overall Response Rate, Disease Control Rate, Time To Response and Duration of Response per Response Evaluation Criteria In Solid Tumors 1.1 (by Blinded independent review committee and local Investigators assessment);To compare overall survival (OS) in the two treatment armsTimepoint: Overall Survival <br/ ><br> <br/ ><br>Overall Survival (OS), defined as the time from date of randomization to the date of death due to any cause.