Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)

Study Overview
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Brief Summary
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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).

Official Title
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A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC

Conditions
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Non-small Cell Lung Cancer, Stage II-IIIA, Immunotherapy, Neoadjuvant Therapy

Intervention / Treatment
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* Drug: Serplulimab and Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue. Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities. Eligible male and female subjects aged 18-75 years. Lung function capacity capable of tolerating the proposed lung surgery. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Available tissue of primary lung tumor. Exclusion Criteria: Presence of locally advanced, inoperable or metastatic disease. Subjects with EGFR mutation or ALK、ROS1 gene rearrangement. Participants with active, known or suspected autoimmune disease. Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors). Other protocol defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serplulimab plus platinum doublet chemotherapy<br> | Drug: Serplulimab and Chemotherapy<br>* Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Pathologic Response (MPR) Rate | 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 | From start of treatment to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response (pCR) Rate | Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy | From start of treatment to 6 months | 
| R0 resection rate | The complete resection rate is the proportion of patients with complete resection | From start of treatment to 6 months | 
| Objective remission rate(ORR) | Objective response rate according to RECIST 1.1 | approximately up to 12 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. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. | From enrollment to disease progression, reoccurrence, or death due to any cause.(Up to a median of 22 months) |