Long-term outcomes after first-line tislelizumab plus chemotherapy in advanced squamous NSCLC
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
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 |
|---|---|
| Enrollment | 109 (estimated) |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07478809 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.