NCT07478809

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 28, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 5, 2026

Last Update Submit

March 23, 2026

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    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 Arms (1)

Extension Cohort

Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion

Other: No intervention

Interventions

No interventionOTHER

No intervention

Extension Cohort

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion

You may qualify if:

  • Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Zhijie Wang, MD

CONTACT

+86 13466323860jie_969@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 18, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)