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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab Plus Chemotherapy Arm | Experimental | 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]) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab Plus Chemotherapy | Drug | 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response Rate | No more than 10% of tumor cells were found in neoadjuvant surgical specimens | 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 | From date of surgery to 14 days later |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number and percentage of cases of all adverse events | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xue Meng, MD, PhD | Contact | +86-17653115602 | mengxue5409@163.com | |
| Guoxin Cai, MD | Contact | +33-751440039 | Guoxin.CAI@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital and Institute | Recruiting | Jinan | Shandong | 250117 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42320986 | Derived | Cai G, Song P, Wang Z, Zhao J, Wang K, Li M, Wang X, Zhu J, Xu J, Huang B, Han X, Zhou H, Xie C, Fu S, Jia H, Teng F, Wang S, Sun H, Li W, Yu J, Meng X. Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study. J Immunother Cancer. 2026 Jun 19;14(6):e015604. doi: 10.1136/jitc-2026-015604. | |
| 40348946 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 24 months |
| Derived |
| Wang K, Wang X, Meng X, Zhang G, Cai G. Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC. Ann Nucl Med. 2025 Aug;39(8):862-874. doi: 10.1007/s12149-025-02057-0. Epub 2025 May 10. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |