Serplulimab versus nivolumab with chemotherapy before surgery for resectable stage II–IIIA squamous lung cancer
A Randomized, Open-label, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Serplulimab Combined With Chemotherapy Versus Nivolumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIa Squamous NSCLC.
This study will test whether giving serplulimab plus chemotherapy before surgery works better than nivolumab plus chemotherapy in adults with resectable stage II–IIIA squamous non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | serplulimab, nivolumab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07398937 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label phase 2 trial planning to enroll 116 patients with histologically confirmed resectable stage II–IIIA squamous NSCLC. Participants are randomized to receive neoadjuvant serplulimab plus chemotherapy or nivolumab plus chemotherapy followed by surgical resection. The study will compare safety and efficacy outcomes, including pathological response and surgical feasibility, between the two arms. The protocol is listed as ECTOP-1036 and is being conducted at Fudan University Shanghai Cancer Center.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically confirmed, resectable stage II–IIIA squamous NSCLC who are fit for complete lung resection and have ECOG performance status 0–1 are ideal candidates.
Not a fit: Patients with non-squamous histology (including adenocarcinoma or mixed types), known EGFR/ALK/ROS1 driver alterations, central nervous system metastases, or severe allergy to the chemotherapy agents are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the regimen with serplulimab could increase tumor shrinkage before surgery and improve surgical outcomes and longer-term disease control for eligible patients.
How similar studies have performed: Previous neoadjuvant studies combining PD-1 inhibitors with chemotherapy have shown improved pathological response rates in resectable NSCLC, but serplulimab itself is less well studied in this specific setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years at time of study entry. 2. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology. 3. The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology; 4. Able to tolerate complete lung cancer resection; 5. WHO/ECOG performance status of 0 or 1. Exclusion Criteria: 1. 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. 2. EGFR sensitivity mutation or ALK, ROS1 gene rearrangement; 3. Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs; 4. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.