About this trial
This study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent curative-intent treatment .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients voluntarily participate in this study and sign informed consent forms (including consent for relevant testing of collected biological samples).
Disqualifiers
1. Patients with NSCLC harboring driver mutations (e.g., EGFR, ALK, ROS1). 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies targeting T-cell co-stimulatory pathways.
Trial design
Single group
Treatments tested in this trial
chemoimmunothrapy
DrugPatients will receive 3-4 cycles of induction therapy with Sintilimab combined with platinum-based doublet chemotherapy, followed by multidisciplinary team (MDT) evaluation. For patients deemed eligible for radical lung primary lesion resection, surgery should be performed within 4-6 weeks after completing the final cycle of chemoimmunotherapy. The timing of radiotherapy for metastatic lymph nodes will be determined by MDT discussion. If deemed inoperable after induction therapy by MDT, definitive radiotherapy will be administered subsequently. All patients, in the absence of contraindications, will receive PD-1 inhibitor maintenance therapy for 1 year following local treatment.
Treatment groups
Trial outcomes
Primary outcomes
conversion rate
the conversion rate to curative primary lung lesion resetion in patients with unresectable stage IIIB-IIIC NSCLC following induction chemoimmunotherapy
1-y PFS
the proportion of patients without disease progression in one year after the initial dose of chemoimmumotherapy
Secondary outcomes
safety
types and incidence of adverse events occurring during the treatment period
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
the rate of pathological complete response (pCR)
the proportion of patients who achieve pCR among those receiving pneumonectomy
PFS
progression-free survival
Other outcomes
the survival impact of different treatment modalities for contralateral hilar or mediastinal lymph node metastasis
the survival differences between patients with contralateral hilar or mediastinal lymph node metastasis who received contralateral lymph node radiotherapy versus surgical lymph node dissection
Locations
Sponsors and contacts
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