NCT06477523

Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC

Phase 1b/2 Study of AK104 (Anti-PD1/CTLA4 Bispecific Antibody) in Combination With Etoposide and Carboplatin Plus Low-dose Radiotherapy (LDRT) for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment for patients with ES-SCLC.

Detailed description

This trial aims to assess the safety and efficacy of a new therapeutic strategy that combines to low-dose radiotherapy combination With AK104 plus etoposide and carboplatin/cisplatin.

Conditions

• SCLC, Extensive Stage

Interventions

Type	Name	Description
DRUG	AK104	IV infusion
DRUG	Etoposide	Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
DRUG	Carboplatin	Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
RADIATION	low-dose radiotherapy	The subjects will receive LDRT, from C1D1-C1D5, once a day for 3Gy, until the target dose of 15Gy is achieved (Cycles 1). LDRT treatment for primary/mediastinal positive lymph nodes/metastatic lesions during maintenance therapy (C1D1-C1D5, 15Gy).

Timeline

• Start date: 2024-05-16
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

2 sites across 1 country: China