Evaluating Serplulimab with Chemotherapy for Treating Resectable Lung Cancer
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
This study is testing if adding a new drug called Serplulimab to chemotherapy can help people with early-stage lung cancer before and after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | Serplulimab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05775796 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of Serplulimab combined with chemotherapy in patients with resectable Non-Small Cell Lung Cancer (NSCLC) at stages II to IIIA. It involves administering the treatment both before (neoadjuvant) and after (adjuvant) surgical resection of the tumor. Participants will be closely monitored for treatment outcomes and any potential side effects. The study is being conducted by the Eastern Cooperative Thoracic Oncology Project at Fudan University.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with operable stage IB-IIIA NSCLC who can tolerate lung surgery.
Not a fit: Patients with locally advanced, inoperable disease or specific genetic mutations like EGFR or ALK may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve survival rates and outcomes for patients with resectable NSCLC.
How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy for lung cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Fangqiu Fu, M.D.
- Email: fufangqiu12@163.com
- Phone: 021-64175590
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.