Back to resultsEvaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
Primary Purpose
Non-small Cell Lung Cancer, Stage II-IIIA, Immunotherapy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Serplulimab and Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Serplulimab plus platinum doublet chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pathologic Complete Response (pCR) Rate
Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy
R0 resection rate
The complete resection rate is the proportion of patients with complete resection
Objective remission rate(ORR)
Objective response rate according to RECIST 1.1
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05775796
Brief Title
Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Stage II-IIIA, Immunotherapy, Neoadjuvant Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serplulimab plus platinum doublet chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Serplulimab and Chemotherapy
Intervention Description
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
Primary Outcome Measure Information:
Title
Major Pathologic Response (MPR) Rate
Description
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
From start of treatment to 6 months
Secondary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy
Time Frame
From start of treatment to 6 months
Title
R0 resection rate
Description
The complete resection rate is the proportion of patients with complete resection
Time Frame
From start of treatment to 6 months
Title
Objective remission rate(ORR)
Description
Objective response rate according to RECIST 1.1
Time Frame
approximately up to 12 months
Title
Event-Free Survival (EFS)
Description
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.
Time Frame
From enrollment to disease progression, reoccurrence, or death due to any cause.(Up to a median of 22 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangqiu Fu, M.D.
Phone
021-64175590
Email
fufangqiu12@163.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangqiu Fu, M.D.
Phone
021-64175590
Email
fufangqiu12@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
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