This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
Age 18-75
Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
Absence of EGFR, ALK, and ROS1 gene mutations
Eastern Cooperative Oncology Group (ECOG) status 0-1
Patients diagnosed with any other malignant tumor
Have received prior therapy with chemotherapy or immune checkpoint inhibitor
Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
Single group
Camrelizumab Plus Chemotherapy
DrugPatients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])
Major Pathological Response Rate
No more than 10% of tumor cells were found in neoadjuvant surgical specimens
Pathologic complete response rate
No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes
Adverse events
Number and percentage of cases of all adverse events
Disease-free survival
The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason
Molecular imaging research and biomarker analysis
Plasma ctDNA testing, serum metabolomics testing, 18F-FDG uptake value, circulating immunological biomarkers, and observation of tumor immune microenvironment
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