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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients 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 \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
RECRUITINGMajor Pathological Response Rate
No more than 10% of tumor cells were found in neoadjuvant surgical specimens
Time frame: From date of surgery to 14 days later
Pathologic complete response rate
No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes
Time frame: From date of surgery to 14 days later
Adverse events
Number and percentage of cases of all adverse events
Time frame: 24 weeks
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
Time frame: 24 months
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