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

Fudan University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. * 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

Outcomes

Primary Outcomes

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

Time frame: Up to 6 months

Secondary Outcomes

Rate of Pathologic Complete Response (pCR)

Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy

Time frame: Up to 6 months

Rate of R0 resection

The complete resection rate is the proportion of patients with complete resection

Time frame: Up to 6 months

Objective remission rate(ORR)

Objective response rate according to RECIST 1.1

Time frame: 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.

Time frame: 2 years

Immune infiltrations in tumor-draining lymph nodes

Immune cell subtype infiltrations in tumor-draining lymph nodes by single-cell sequencing

Time frame: 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes