Combining serplulimab with chemotherapy for lung cancer treatment
A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
This study is testing if combining a new immunotherapy drug called serplulimab with chemotherapy can help people with lung cancer live longer and reduce the chances of their cancer coming back after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | serplulimab, chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05882513 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of serplulimab, an immunotherapy drug, combined with chemotherapy as a neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). The study aims to improve postoperative survival rates and reduce the risk of tumor recurrence by utilizing this combination therapy before surgical resection. Participants will undergo treatment followed by surgery, with tumor samples collected for analysis. The trial is conducted at the Second Affiliated Hospital of Zhejiang University in China, where the incidence of NSCLC is notably high.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed, resectable non-small cell lung cancer at clinical stages IIA-IIIB.
Not a fit: Patients with significant cardiovascular disease, distant metastases, or a history of autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance survival rates and reduce recurrence in patients with non-small cell lung cancer.
How similar studies have performed: Preliminary results from other studies using PD-1/PD-L1 inhibitors in combination with chemotherapy have shown promising outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. signed informed consent; 2. patients age 18 to 75 years old 3. primary resectable, histologically confirmed non small cell lung cancer; 4. non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition). 5. ECOG PS 0-1. 6. the diseases could be resectable assessed by thoracic oncologist Exclusion Criteria: 1. with significant cardiovascular disease; 2. current treatment with anti-viral therapy or HBV; 3. Female patients who are pregnant or lactating; 4. history of malignancy within 5 years prior to screening; 5. active or history of autoimmune disease or immune deficiency; 6. signs of distant metastases.
Where this trial is running
Hangzhou
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Ming Wu
- Email: iwuming22@zju.edu.cn
- Phone: +8613757118715
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.