Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major pathological response
Time Frame: ;usually 1 week after surgery
|
viable tumor cell less than 10%
|
;usually 1 week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
R0 resection rate
Time Frame: ,usually 1 week after surgery
|
margin negative resection
|
,usually 1 week after surgery
|
|
Down-staging rate
Time Frame: usually 1 week after surgery
|
clinical and pathological downstaging
|
usually 1 week after surgery
|
|
Impact of Neoadjuvant Therapy on Surgical Outcomes
Time Frame: usually 1 week after surgery
|
Surgical Rate
|
usually 1 week after surgery
|
|
The outcome of survival
Time Frame: usually 12 month after Induction Therapy
|
patterns and Outcomes of Postoperative Disease Recurrence/Progression
|
usually 12 month after Induction Therapy
|
|
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;
|
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
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;
|
from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLOG-0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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