NCT06719700

Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

A Prospective Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.

Detailed description

This single-arm Phase II study aims to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC. In this single-arm, Phase II study, patients are planned to receive four cycles of etoposide combined with either cisplatin or carboplatin, along with toripalimab and surufatinib. During chemotherapy, patients will undergo concurrent radiotherapy. Following chemoradiotherapy, consolidation treatment with toripalimab and surufatinib will be administered. Prophylactic cranial irradiation (PCI) is recommended prior to the consolidation therapy.

Conditions

• Toripalimab
• Surufatinib
• Chemoradiotherapy
• Limited-stage Small Cell Lung Cancer (LS-SCLC)

Interventions

Type	Name	Description
DRUG	Chemotherapy	Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.
DRUG	Immunotherapy	Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.
DRUG	Angio-immuno kinase inhibitor	Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.
RADIATION	radiotherapy	Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.
RADIATION	Prophylactic Cranial Irradiation	PCI is recommended after the completion of chemoradiotherapy.
DRUG	Consolidation Therapy with Toripalimab and Surufatinib	Patients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.

Timeline

• Start date: 2024-11-30
• Primary completion: 2028-11-29
• Completion: 2028-11-29
• First posted: 2024-12-06
• Last updated: 2026-03-03

Locations

1 site across 1 country: China