A Retrospective Real-World Study Based on RATIONALE-307

The study aims to retrospectively collect long-term survival data from patients who received first-line tislelizumab combined with chemotherapy in the RATIONALE-307 trial, in order to enrich the evidence on long-term benefits in advanced squamous NSCLC patients from immunotherapy and to identify patients deriving greater clinical advantage.

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Key information

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, China

Location status: Recruiting

Location contact

Wang Zhijie

CONTACT

[email protected]

+8613466323860

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

Overall Survival (OS)

Time frame: Defined as the time from the date of randomization in the RATIONALE-307 trial to the date of death from any cause occurring on or before December 31, 2025.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhijie Wang, MD

CONTACT

[email protected]

+86 13466323860

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 18, 2026
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting