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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775796
• Other study ID #: HLX10IIT21
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: Fangqiu Fu, M.D.
• Phone: 021-64175590
• Email: fufangqiu12[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy
• Neoadjuvant Therapy
• Non-small Cell Lung Cancer

Intervention

Drug:
• Serplulimab and Chemotherapy
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	R0 resection rate	The complete resection rate is the proportion of patients with complete resection	From start of treatment to 6 months
Secondary	Objective remission rate(ORR)	Objective response rate according to RECIST 1.1	approximately up to 12 months
Secondary	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)