NCT07349225

Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer

A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The Second Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer.

Detailed description

This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. As well as, this study aimed to longitudinally monitor the dynamic changes of molecular residual disease in patients with extensive-stage small cell lung cancer to evaluate treatment efficacy and explore the potential application value of MRD as a biomarker for efficacy assessment.

Conditions

• ES-SCLC

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection	Induction Therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks for 4 to 6 cycles. Maintenance therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks. Maintenance therapy was continued for up to 2 years or until disease progression (PD), intolerable toxicity, withdrawal of informed consent, investigator-determined subject discontinuation from the study, non-compliance with study treatment or procedures, or other reasons specified in the protocol.
DRUG	Etoposide	Induction Therapy: etoposide, 100 mg/m2, D1-3, every 3 weeks for 4 to 6 cycles.
DRUG	Cisplatin	Induction Therapy: cisplatin, 25 mg/m², D1-3, every 3 weeks for 4 to 6 cycles.
RADIATION	Targeted Radiation Therapy	Subjects who achieved a CR, PR, or SD with good local control following induction therapy, were subjected to sequential TRT (≥3Gy×10 or 15, using an involved-field irradiation technique. The specific regimen could be adjusted according to the patient's disease status and the standard practices of the investigator's institutional radiation oncology department)

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-12-31
• Completion: 2028-02-28
• First posted: 2026-01-16
• Last updated: 2026-01-16