Clinical trial NCT06829641: Clinical Outcomes of Tislelizumab Combined with Chemotherapy As Induction Therapy in Stage III (cTNM-IIIB/IIIC) NSCLC
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NSCLC Stage IIIB, NSCLC Stage IIIC
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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 2-4 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.

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.

Primary outcomes:
measure: major pathological response
timeFrame: ;usually 1 week after surgery
Secondary outcomes:
measure: R0 resection rate
timeFrame: ,usually 1 week after surgery
measure: Down-staging rate
timeFrame: usually 1 week after surgery
measure: Impact of Neoadjuvant Therapy on Surgical Outcomes
timeFrame: usually 1 week after surgery
measure: The outcome of survival
timeFrame: usually 12 month after Induction Therapy
measure: 12month event-free survival rate
timeFrame: 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
measure: OS
timeFrame: from date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
Other outcomes:
Locations:
Study officials:
References: