This is a prospective, open, multicenter, Phase II single-arm clinical study. In subjects with an initial stage of stage III-N3 non-small cell lung cancer (NSCLC) that was negative for sensitive gene mutations and had not received any systemic or local therapy (T1-4N3M0, excluding primary tumor or metastatic lymph node invasion of the aorta/trachea/esophagus/heart, etc.); After 3-4 cycles of Tislelizumab combined with platinum-containing dual agents, the patients without disease progression were evaluated by MDT and selected according to the patient's wishes, including those who could receive conventional/standard radical lung cancer surgery (excluding total lung resection). Conventional/standard resection of primary, ipsilateral hilum and ipsilateral mediastinum combined with hypofractionted chemoradiotherapy of N3 metastatic lymph nodes was performed. For patients who are inoperable or unwilling to undergo surgery or intolerant to surgery, conventional concurrent chemoradiotherapy is given. Maintenance therapy with Tislelizumab was continued after local treatment until disease progression, drug intolerance as assessed by imaging, or after 1 year; Participants were followed up according to the procedure to evaluate efficacy and patient-reported outcomes.
The study included a screening period (no more than 28 days after subjects signed informed consent to the first dose), a treatment period (including Tislelizumab combined with chemotherapy-restaging and MDT-local treatment-maintenance therapy), and a follow-up period.
Thirty patients：30 patients Primary endpoint: 1-year EFS rate Secondary endpoints: EFS, OS, surgical rate, TTDM, TTLR, AEs, PROs Exploratory end points: Imaging efficacy, pathological efficacy and other relevant clinical outcomes; Predictive biomarkers based on tissue and blood samples.
Aged 18 years or older (inclusive);
Willingness to participate and provide written informed consent;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, with no deterioration in the two weeks prior to treatment, and an expected survival of at least 12 weeks;
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), T1-4N3M0 (AJCC 9th edition); suspicious lymph nodes on whole-body 18F-fluorodeoxyglucose positron emission tomography (PET) or contrast-enhanced computed tomography (CT) or PET-CT should undergo invasive lymph node staging which can be confirmed through endobronchial ultrasound, mediastinoscopy, thoracoscopy, or needle biopsy; however, mandatory confirmation is not required for highly suspicious mediastinal lymph nodes in zones 5 and 6;
Diagnosed with Pancoast tumor;
Pathologically confirmed large cell neuroendocrine carcinoma (LCNEC);
Primary tumor or metastatic lymph nodes infiltrating major vessels/aorta, trachea, esophagus, heart, etc.;
Any of the following prior treatments: ① Previous lung surgery; ② Prior systemic chemotherapy, immunotherapy, targeted therapy, or any other anti-tumor treatment for lung cancer; ③ Known presence of epidermal growth factor receptor (EGFR) mutations, ALK rearrangements, ROS1 rearrangements, BRAF V600 mutations, RET rearrangements, MET exon 14 skipping mutations, NTRK1/2/3 rearrangements, or other sensitive mutations; ④ Prior radiotherapy to the lungs; ⑤ Major surgery within 14 days prior to first dose or within 28 days if not fully recovered from toxicity and/or complications; ⑥ Use of traditional Chinese medicine with anti-tumor effects is allowed if discontinued at least 2 weeks before study drug administration and used for no more than 7 days;
Single group
3-4 cycles of Tislelizumab combined with platinum-based chemotherapy, evaluated by MDT and assigned to treatment strategies based on eligibility and patient preference.
DrugPatients deemed eligible to surgery will receive standard lung cancer resection (excluding total pneumonectomy)
1-year EFS rate
The 1-year Event-Free Survival (EFS) rate is defined as the proportion of patients who have not experienced an EFS event at one year after the first administration of the study drug. EFS is defined as the time from the first dose of the study treatment until the first objective documentation of disease progression that renders the patient unresectable or ineligible for curative radiotherapy, local recurrence, distant metastasis, or death from any cause, whichever occurs first. EFS is assessed by the investigator based on RECIST v1.1 criteria using the curative intent treatment analysis set.
Secondary endpoints: EFS, OS, surgical rate, TTDM, TTLR, AEs, PROs
OS: The duration from study enrollment to death from any cause. Surgical rate: Percentage of operable patients receiving surgical resection. TTDM: The percentage of patients from enrollment to the first detection of tumor metastasis in distant organs or tissues compared to the number of patients in the corresponding treatment group. TTLR: The percentage of patients with tumor recurrence at the primary lesion or adjacent area after treatment compared to the number of patients in the corresponding treatment group. AEs: Classify and grade adverse events according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE), and assess the incidence, severity, and causal relationship of treatment-related adverse events. PROs: Collect data directly from patients regarding their health status or treatment impact using specific tools (such as FACT-G), without interpretation by healthcare professionals, to provide a patient perspective on treatment effects.
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