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This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC). The study also intended to explore the immune function of tumor-draining lymph nodes during immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab plus platinum doublet chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab and Chemotherapy | Drug | Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Pathologic Response (MPR) | Major pathologic response (MPR) rate is defined as after neoadjuvant treatment, the percentage of residual tumor cells in the tumor bed ≤ 10%, regardless of the proportion of patients with residual tumor cells in lymph nodes | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Pathologic Complete Response (pCR) | Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy | Up to 6 months |
| Rate of R0 resection | The complete resection rate is the proportion of patients with complete resection |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114951 | Derived | Fu F, Wu H, Deng C, Chen H, Huang Q, Yuan C, Ding X, Ye T, Zhou Y, Chen S, Sun Y, Zhang Y, Xiang J, Wang S, Li Y, Li B, Lu Y, Zhang Y, Hu H, Chen H. Simplified perioperative serplulimab and chemotherapy for resectable squamous NSCLC: a phase II trial with biomarker analysis. J Immunother Cancer. 2026 May 11;14(5):e014437. doi: 10.1136/jitc-2025-014437. |
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| Up to 6 months |
| Objective remission rate(ORR) | Objective response rate according to RECIST 1.1 | Up to 6 months |
| Event-Free Survival (EFS) | Event-free survival (EFS) is defined as the length of time from enrollment to any of the following events: any progression of disease precluding surgery, progression or recurrence disease assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Patients who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. | 2 years |
| Immune infiltrations in tumor-draining lymph nodes | Immune cell subtype infiltrations in tumor-draining lymph nodes by single-cell sequencing | 2 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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