Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer: individual-patient-data and study-level analyses
Not Applicable
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000047001
- Lead Sponsor
- Yokohama City University Hospital
- Brief Summary
See below: N Horita. Tumor Response, Disease Control, and Progression-Free Survival as Surrogate Endpoints in Trials Evaluating Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: Study- and Patient-Level Analyses. Cancers (Basel). 2023 Jan; 15(1): 185.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 3312
Inclusion Criteria
Not provided
Exclusion Criteria
[Independent-patient-level analysis part] Not defined. [Study-level analysis part] Non-English article and conference abstract.
Study & Design
- Study Type
- Others,meta-analysis etc
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This study consist of two parts: independent-patient-data analysis and trial-level analysis parts. [Independent-patient-level analysis part] Patients will be classified based on RECIST evaluation, CR, PR, SD, and PD. Then, overall survivals will be compared between group using hazard ratio. Correlation between PFS and OS will be also assessed. [Study-level analysis part] The weighted Spearman's rank correlation coefficient (r) will be used as the indicator to assess the surrogacy. The correlation with HRos will be assessed for ORorr, ORdcr, and HRpfs.
- Secondary Outcome Measures
Name Time Method