About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Camrelizumab Plus Chemotherapy