Long-term outcomes after first-line tislelizumab plus chemotherapy in advanced squamous NSCLC
Official title: Long-Term Efficacy and Safety Analysis of First-Line Tislelizumab in Patients With Advanced Squamous NSCLC: a Retrospective Real-World Study Based on RATIONALE-307
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT07478809 · Data updated 2026-11-12
This project collects long-term survival data from people with advanced squamous non-small cell lung cancer who received first-line tislelizumab plus chemotherapy in RATIONALE-307 to see who benefited most.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 109 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | February 28, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07478809 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with advanced squamous NSCLC who participated in the RATIONALE-307 trial and were alive at the end of that trial's follow-up period.
✕Probably not a fit
Patients who did not enroll in RATIONALE-307, who have non-squamous NSCLC, or who had a documented death before RATIONALE-307 completion are not eligible and would not directly benefit from this retrospective analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This retrospective observational effort gathers extended follow-up and survival information on participants in the RATIONALE-307 trial who received first-line tislelizumab plus chemotherapy. Investigators will use medical records and registry data to capture overall survival, duration of response, and other long-term outcomes beyond the original trial period. Analyses will search for clinical and demographic factors associated with greater durable benefit and may include subgroup comparisons. No new treatments are given; the project aims to enrich real-world evidence on long-term immunotherapy effectiveness in squamous NSCLC.
Why it matters
Potential benefit: If successful, the findings could help identify which patients with squamous NSCLC are most likely to experience long-term survival after first-line tislelizumab plus chemotherapy.
How similar studies have gone: Other trials of PD-1/PD-L1 immunotherapies in advanced NSCLC have shown durable responses and long-term survival in subsets of patients, though long-term real-world data specific to tislelizumab in squamous NSCLC remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion Exclusion Criteria: * Patients who had a documented death before study completion in the RATIONALE-307 trial
Where it's running
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China Recruiting
Study contacts
- Study coordinator: Zhijie Wang, MD
- Email: jie_969@163.com
- Phone: +86 13466323860
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.