Serplulimab versus nivolumab with chemotherapy before surgery for resectable stage II–IIIA squamous lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.