Clinical Outcomes of Tislelizumab Combined With Chemotherapy as Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab Combined with Chemotherapy,.
- Who it may be relevant to
- Registry conditions: NSCLC Stage IIIB, NSCLC Stage IIIC. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Procedure Tislelizumab Combined with Chemotherapy,
Tislelizumab Combined with Chemotherapy as Induction Therapy
Primary outcome measures
- major pathological response [Time frame: ;usually 1 week after surgery]
Secondary outcome measures (6)
- R0 resection rate [Time frame: ,usually 1 week after surgery]
- Down-staging rate [Time frame: usually 1 week after surgery]
- Impact of Neoadjuvant Therapy on Surgical Outcomes [Time frame: usually 1 week after surgery]
- The outcome of survival [Time frame: 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]
- OS [Time frame: from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06829641 · CLOG-0004