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

NCT ID: NCT06829641

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-09
• Study Completion Date: 2026-12-01

Brief 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 cancer (NSCLC) patients from multiple tertiary hospitals in real-world settings since August 2020 being collected and analyzed.

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:

1. Patient clinical characteristics

2. Treatment patterns

3. Treatment compliance

4. Safety profiles

5. Event-free survival (EFS) and overall survival (OS) tracking

Conditions

NSCLC Stage IIIB, NSCLC Stage IIIC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Tislelizumab Combined with Chemotherapy,

Tislelizumab Combined with Chemotherapy as Induction Therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qinghua

Academic Director of the Lung Cancer Center at West China Hospital, Sichuan Universit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CLOG-0004

Identifier Type: -

Identifier Source: org_study_id