Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)
- Sponsor
- Guangdong Provincial People's Hospital
- Study ID
- NCT06911606
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- SCLC, Limited Stage
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin — DRUGAfter 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy
Study Details
This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC
Key Dates
- Start date
- May 22, 2024
- Status verified
- Mar 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 4 cycles of Serplulima plus platinum-containing dual drugAfter 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy
Primary Outcome Measure
pathological complete response rate [ Time Frame: Within 2 weeks after radical surgery ]
Central Contacts
- Chen Huang, MD+8616620159730