NSCLC Stage IIIB, NSCLC Stage IIIC
Conditions
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 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
PROCEDURETislelizumab Combined with Chemotherapy,
Tislelizumab Combined with Chemotherapy as Induction Therapy
Sponsors
West China Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major pathological response | ;usually 1 week after surgery | viable tumor cell less than 10% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Down-staging rate | usually 1 week after surgery | clinical and pathological downstaging |
| Impact of Neoadjuvant Therapy on Surgical Outcomes | usually 1 week after surgery | Surgical Rate |
| R0 resection rate | ,usually 1 week after surgery | margin negative resection |
| 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 | 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; |
| OS | 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; |
| The outcome of survival | usually 12 month after Induction Therapy | patterns and Outcomes of Postoperative Disease Recurrence/Progression |
Outcome results
None listed