Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC

NCT07398937 | Recruiting Phase 2

• 1 other identifier: HLX10IIT314
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.

Conditions

Resectable Stage II-IIIa Squamous NSCLC

Keywords

lung cancer; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete remission (PCR) rate

  Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator.

  From randomization up to a median of 30 months after randomization

Study Arms (2)

Serplulimab + chemotherapy

EXPERIMENTAL

Serplulimab injection \[300 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;

Drug: Serplulimab + chemotherapy

Nivolumab + chemotherapy

ACTIVE COMPARATOR

Nivolumab \[360 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;

Drug: Nivolumab + chemotherapy

Interventions

Serplulimab + chemotherapy DRUG

Serplulimab injection \[300 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles

Serplulimab + chemotherapy

Nivolumab + chemotherapy DRUG

Nivolumab \[360 mg, administered on Day 1, Q3W (once every 3 weeks)\] + paclitaxel (albumin-bound) for injection \[260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W\] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;

Nivolumab + chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 75 years at time of study entry.
• The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology.
• The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology;
• Able to tolerate complete lung cancer resection;
• WHO/ECOG performance status of 0 or 1.

You may not qualify if:

• Other pathological histological types of non-small cell lung cancer subjects, including adenocarcinoma subjects, squamous-adenocarcinoma mixed cancer subjects, and NSCLC containing components of small cell lung cancer and neuroendocrine carcinoma.
• EGFR sensitivity mutation or ALK, ROS1 gene rearrangement;
• Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs;
• Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Drug Therapy; Nivolumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)