Immunotherapy, Neoadjuvant Therapy, Non-small Cell Lung Cancer, Stage II-IIIA
Conditions
Brief summary
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.
Interventions
DRUGSerplulimab and Chemotherapy
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Pathologic Response (MPR) | Up to 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Pathologic Complete Response (pCR) | Up to 6 months | Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy |
| Rate of R0 resection | Up to 6 months | The complete resection rate is the proportion of patients with complete resection |
| Objective remission rate(ORR) | Up to 6 months | Objective response rate according to RECIST 1.1 |
| Event-Free Survival (EFS) | 2 years | 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. |
| Immune infiltrations in tumor-draining lymph nodes | 2 years | Immune cell subtype infiltrations in tumor-draining lymph nodes by single-cell sequencing |
Countries
China
Outcome results
None listed