NCT07289048

A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression

A Prospective, Single-Arm, Exploratory Clinical Study of IBI363 in Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Following Progression on Immunotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, exploratory clinical trial designed to evaluate the efficacy and safety of IBI363 in patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after at least two prior lines of standard therapy, including PD-1/PD-L1 inhibitor-based immunotherapy. A total of 35 patients were enrolled. The primary endpoint is the objective response rate (ORR), as assessed by investigators according to RECIST 1.1 criteria. Following a screening period of up to 28 days, patients will receive IBI363 treatment until disease progression, onset of intolerable toxicity, withdrawal of informed consent, completion of 24 months of therapy, discontinuation due to other protocol-specified reasons, or early termination of the study.

Conditions

• SCLC,Extensive Stage

Interventions

Type	Name	Description
DRUG	IBI363（PD-1/IL-2a-bias）	The administration route of IBI363 is intravenous infusion. Based on the cumulative safety data of IBI363 monotherapy, the administration protocol of IBI363 adopts the Priming design. The subjects will receive 1 dose of 100 μg/kg (initial dose) of IBI363 on the first day of the first cycle (C1D1), aIBI363（PD-1/IL-2a-bias）nd then the target dose of 3 mg/kg Q3W IBI363 will be administered starting 7 days later. The administration period except for the first cycle is 21 days (the first cycle lasts for 28 days).

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-12-17
• Last updated: 2025-12-17