Correlation with overall survival of response rate (RR) and disease control rate (DCR) in phase II randomized controlled trials evaluating second- or later-line chemotherapy for advanced, locally advanced, and recurrent non-small cell lung cancer.
- Conditions
- SCLC
- Registration Number
- JPRN-UMIN000040412
- Lead Sponsor
- Yokohama City University
- Brief Summary
Please see: Transl Lung Cancer Res. 2021 May;10(5):2278-2289. doi: 10.21037/tlcr-20-1120.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9059
Not provided
Study Selection: study design We will include phase II RCTs that evaluate second- or later-line chemotherapy for advanced, locally advanced, and recurrent NSCLC. Articles need to be written up as full articles, brief reports, or conference abstracts regardless of their primary end point. Non-English language reports will be excluded. A phase I/II trial will be allowed. A phase II/III trial will be included when data from phase II part can be extractable Study selection: treatment The interventions include cytotoxic agents, molecular targeted therapies, immune checkpoint inhibitors, and their combinations. Immunotherapy other than immune checkpoint inhibitors will not be included because such treatment is not current standard. Comparison of the same drugs in the form of low-dose versus high-dose or weekly versus 3-weekly regimens will be allowed. Maintenance therapy after the first-line chemotherapy will not considered as the second-line treatment.
Study & Design
- Study Type
- Others,meta-analysis etc
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation with hazard ratio (HR) for OS (HRos) of odds ratio of RR (ORrr), odds ratio of DCR(ORdcr), difference of RR (d-RR, %), and difference of DCR (d-RCR, %) were assessed. Response, stable disease, and disease progression had to be evaluated without considerable deviation from the Response Evaluation Criteria in Solid Tumors (RECIST) 2000 guidelines and the RECIST 2009 revised guidelines.
- Secondary Outcome Measures
Name Time Method