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NCT Number: NCT06829641

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

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.

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Key information

Conditions

NSCLC Stage IIIB, NSCLC Stage IIIC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab Combined with Chemotherapy,

Procedure

Tislelizumab Combined with Chemotherapy as Induction Therapy

Primary outcomes

  1. major pathological response

    Time frame: ;usually 1 week after surgery

    viable tumor cell less than 10%

Secondary outcomes

  1. R0 resection rate

    Time frame: ,usually 1 week after surgery

    margin negative resection

  2. Down-staging rate

    Time frame: usually 1 week after surgery

    clinical and pathological downstaging

  3. Impact of Neoadjuvant Therapy on Surgical Outcomes

    Time frame: usually 1 week after surgery

    Surgical Rate

  4. The outcome of survival

    Time frame: usually 12 month after Induction Therapy

    patterns and Outcomes of Postoperative Disease Recurrence/Progression

  5. 12month event-free survival rate

    Time frame: 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

    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;

  6. OS

    Time frame: from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months

    From diagnosis to the death;

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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