NSCLC (Advanced Non-small Cell Lung Cancer)NCT07478809
A Retrospective Real-World Study Based on RATIONALE-307
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion
Who may be able to join
- Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion
Who cannot join
- Patients who had a documented death before study completion in the RATIONALE-307 trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Wang Zhijie, +8613466323860, jie_969@163.com
About this study
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
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.
- Being tested
- No intervention
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Extension Cohort | Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start28 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478809
- Sponsor's protocol ID
- NCC6036
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07478809
- Acronym / sponsor ID
- NCC6036
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extension Cohort | – | Other: No interventionPatients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion
Key inclusion criteria (1 listed)
- Patients with squamous NSCLC who participated in the RATIONALE-307 trial and had no documented death before study completion
Key exclusion criteria (1 listed)
- Patients who had a documented death before study completion in the RATIONALE-307 trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Extension Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhijie Wang, MD (+86 13466323860, jie_969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.