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ID07478809

Long-Term Efficacy and Safety Analysis of First-Line Tislelizumab in Advanced Squamous NSCLC Patients: A Retrospective Real-World Study Based on RATIONALE-307

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-03-27

109

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to collect long-term survival data from patients with advanced squamous non-small cell lung cancer (NSCLC) who received first-line treatment with tislelizumab combined with chemotherapy in the RATIONALE-307 trial. The goal is to gather more evidence on the long-term benefits of immunotherapy for these patients and to identify those who may gain greater clinical advantage from this treatment approach. The study is observational and involves no new interventions. It focuses on patients who participated in the RATIONALE-307 trial and were alive at the completion of that study. There are no additional treatments or experimental procedures in this follow-up period. Participants will have their overall survival data collected retrospectively, defined as the time from randomization in the RATIONALE-307 trial until death from any cause occurring on or before December 31, 2025. The study will analyze this data to better understand long-term outcomes. Since this is a retrospective study, there is no active involvement or new assessments required from participants beyond data collection.

CONDITIONS

Brief Title

A Retrospective Real-World Study Based on RATIONALE-307

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with squamous NSCLC who participated in the RATIONALE-307 trial
  • Patients who had no documented death before study completion
Not Eligible

You will not qualify if you...

  • Patients who had a documented death before study completion in the RATIONALE-307 trial

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

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Long-term Monitoring

Duration - Up to December 31, 2025

Participants who previously received treatment in the RATIONALE-307 trial are observed for overall survival and safety outcomes over time.

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Trial Site Locations

Total: 1 location

1

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

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Research Team

Z

Zhijie Wang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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