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 .
This study is a prospective phase II trial designed to evaluate the safety and efficacy of radical resection of the primary lung lesion combined with radical radiotherapy for metastatic lymph nodes, followed by sequential PD-1 inhibitor consolidation therapy, in treatment-naïve patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) who received induction therapy with Sintilimab plus platinum-based doublet chemotherapy. The study plans to enroll 39 pathologically confirmed, driver mutation-negative, treatment-naïve stage IIIB-IIIC NSCLC patients. Eligible patients will receive 3-4 cycles of Sintilimab combined with platinum-based doublet induction chemotherapy, followed by assessment for feasibility of radical lung resection.The primary objectives are to evaluate: (1)The conversion rate to curative-intent treatment (radical resection and/or definitive radiotherapy) after induction chemoimmunotherapy in treatment-naïve unresectable stage IIIB-IIIC NSCLC patients; (2) Progression-free survival (PFS) in patients who undergo curative-intent treatment post-induction. Secondary objectives include observation of adverse event rates, objective response rate (ORR), major pathological response (MPR), PFS, overall survival (OS), and exploration of biomarkers associated with treatment efficacy and prognosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Patients 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.
conversion rate
the conversion rate to curative primary lung lesion resetion in patients with unresectable stage IIIB-IIIC NSCLC following induction chemoimmunotherapy
Time frame: up to 20 weeks
1-y PFS
the proportion of patients without disease progression in one year after the initial dose of chemoimmumotherapy
Time frame: within one year
safety
types and incidence of adverse events occurring during the treatment period
Time frame: up to 2 years
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
Time frame: up to 20 weeks
the rate of pathological complete response (pCR)
the proportion of patients who achieve pCR among those receiving pneumonectomy
Time frame: up to 20 weeks
PFS
progression-free survival
Time frame: 5 years
OS
overall survival
Time frame: 5 years
the incidence of radiation pneumonitis
the incidence of radiation pneumonitis
Time frame: 1-2 years
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