NSCLC Stage IIIB, NSCLC Stage IIICNCT06829641

Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC

An observational study of NSCLC Stage IIIB, NSCLC Stage IIIC, run by West China Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes in Stage III (cTNM-IIIB/IIIC) Non-Small Cell Lung Cancer.Patients meeting inclusion and exclusion criteria were enrolled, with treatment modalities and clinical outcomes of stage III non-small cell lung… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: NSCLC Stage IIIB, NSCLC Stage IIIC
What is being tested?: Tislelizumab Combined with Chemotherapy,
Type of treatment: Surgery or procedure
How many people: 200 participants
Where: No sites listed yet
Study dates: 9 Aug 2025to 1 Dec 2026
Phase: Observational

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 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.

Who may be able to join

Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.
No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.
ECOG PS scores of the enrolled patients ranged from 0 to 2.

Who cannot join

Patients with other previous malignancies did not require additional treatment. Patients with incomplete key baseline and treatment information:including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.

About this study

Official title: A Multicenter Real-World Data Pooled Analysis: The Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC

Read the detailed description

Key Inclusion Population： Stage IIIB/IIIC NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.Patients were negative for EGFR-sensitive mutations or ALK/ROS1 fusion alterations.

No prior chemotherapy, radiotherapy, surgical intervention, or immunotherapy had been administered.ECOG PS scores of the enrolled patients ranged from 0 to 2.

Neoadjuvant/Induction Therapy Regimen:

Tislelizumab combined with platinum-based doublet chemotherapy was administered for at Least Two Cycles , followed by surgical resection or other therapeutic interventions (e.g., radiotherapy/chemotherapy). Real-world clinical outcomes were collected and analyzed based on patients' subsequent treatment pathways.Clinical Stage IIIB-IIIC Non-Small Cell Lung Cancer (AJCC 8th Edition Staging); ECOG PS Score 0-2

Retrospective data collection was conducted for cases prior to site initiation, while prospective collection was implemented for post-initiation cases.

Collected parameters include:

Patient clinical characteristics
Treatment patterns
Treatment compliance
Safety profiles
Event-free survival (EFS) and overall survival (OS) tracking

Conditions: NSCLC Stage IIIB, NSCLC Stage IIIC
Being tested: Tislelizumab Combined with Chemotherapy,
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.

Tislelizumab Combined with Chemotherapy,Procedure or surgery
Tislelizumab Combined with Chemotherapy as Induction Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

major pathological response
viable tumor cell less than 10%
Measured: ;usually 1 week after surgery

Secondary outcomes (6)

R0 resection rate
margin negative resection
Measured: ,usually 1 week after surgery
Down-staging rate
clinical and pathological downstaging
Measured: usually 1 week after surgery
Impact of Neoadjuvant Therapy on Surgical Outcomes
Surgical Rate
Measured: usually 1 week after surgery
The outcome of survival
patterns and Outcomes of Postoperative Disease Recurrence/Progression
Measured: usually 12 month after Induction Therapy
12month event-free survival rate
the time from randomization to any progression of disease precluding surgery, progresson or recurrence of disease after surgery, progression of disease in the absence of surgery, or death from any cases;
Measured: rom date of diagnosis until the date of first documented progression, the rate of recurrence or date of death from any cause, whichever came first, assessed up to 12 months
OS
From diagnosis to the death;
Measured: from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 20251 Dec 2026

First posted17 Feb 2025
Study start9 Aug 2025 (estimated)
Primary completion1 Dec 2025 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLC Stage IIIB, NSCLC Stage IIICStudies of the same condition, open and under way.
More trials run by West China HospitalThe sponsor's other registered studies.
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: Other
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06829641
Sponsor's protocol ID: CLOG-0004
Status last verified: Jun 2025
First submitted: 9 Feb 2025
Last updated: 27 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No