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RECRUITING
NCT06477523
PHASE1/PHASE2

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

Sponsor: Sichuan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2024-05-16

Completion Date

2026-12

Last Updated

2024-06-27

Healthy Volunteers

No

Interventions

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).

Locations (2)

China West Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China