Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer

Phase 2

Recruiting

• Conditions: NSCLC; Neoadjuvant Therapy

• Registration Number: NCT05882513
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> 1. signed informed consent;<br><br> 2. patients age 18 to 75 years old<br><br> 3. primary resectable, histologically confirmed non small cell lung cancer;<br><br> 4. non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient)<br> (according to AJCC TNM stage, 8th edition).<br><br> 5. ECOG PS 0-1.<br><br> 6. the diseases could be resectable assessed by thoracic oncologist<br><br>Exclusion Criteria:<br><br> 1. with significant cardiovascular disease;<br><br> 2. current treatment with anti-viral therapy or HBV;<br><br> 3. Female patients who are pregnant or lactating;<br><br> 4. history of malignancy within 5 years prior to screening;<br><br> 5. active or history of autoimmune disease or immune deficiency;<br><br> 6. signs of distant metastases.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (PCR)

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR);Major Pathological Response (MPR);2-year and 5-year overall survival;Incidence of Treatment-related Adverse Events;R0 resection rate;The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients