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

NCT06829641 | Not Yet Recruiting

• 1 other identifier: CLOG-0004
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC Stage IIIB, NSCLC Stage IIIC

Outcome Measures

Primary Outcomes (1)

• major pathological response

  viable tumor cell less than 10%

  ;usually 1 week after surgery

Secondary Outcomes (6)

• R0 resection rate

  ,usually 1 week after surgery

• Down-staging rate

  usually 1 week after surgery

• Impact of Neoadjuvant Therapy on Surgical Outcomes

  usually 1 week after surgery

• The outcome of survival

  usually 12 month after Induction Therapy

• 12month event-free survival rate

  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

Interventions

Tislelizumab Combined with Chemotherapy, PROCEDURE

Tislelizumab Combined with Chemotherapy as Induction Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Director of the Lung Cancer Center at West China Hospital, Sichuan Universit

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 17, 2025
• Study Start: August 9, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share