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

NCT07289048•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 75 years (inclusive), male or female.
•2. Histologically confirmed small cell lung cancer (SCLC).
•3. Extensive-stage SCLC refractory to 2 to 3 prior lines of systemic anti-tumor therapy, which must have included PD-1/PD-L1 immunotherapy.
•4. At least one measurable target lesion as per RECIST 1.1 criteria. The target lesion must be measurable (longest diameter ≥10 mm at baseline, or for lymph nodes, short-axis diameter ≥15 mm) and not have been previously irradiated, or have demonstrated clear progression after local therapy. Lesions solely within the brain are not acceptable as target lesions.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•6. Life expectancy ≥ 3 months.
•7. Adequate organ function,
•8. Fertile patients (male and female) must agree to use highly effective contraception (e.g., hormonal, barrier methods, or abstinence) with their partner during the trial and for at least 6 months after the last dose. A serum pregnancy test for women of childbearing potential must be negative within 7 days prior to the first study dose.
•9. Subjects must provide written informed consent before initiating any study-specific procedures.
•10. Active infection requiring intravenous anti-infective therapy at the time of screening.
+12 more criteria

Exclusion Criteria

•1. Histological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed non-small cell lung cancer (e.g., SCLC transformed from NSCLC), or transformed SCLC (e.g., NSCLC transformed to SCLC).
•2. Known history of hypersensitivity (≥ Grade 3 per CTCAE v5.0) to any antibody-based therapeutic agent, or known hypersensitivity to the active substance or inactive excipients of the investigational product.
•3. Major surgical procedure (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of study treatment, or anticipation of the need for elective surgery during the study period.
•4. Systemic corticosteroid therapy (\>10 mg/day prednisone or equivalent) within 14 days prior to the first dose of study treatment, with the following exceptions: topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use (e.g., for contrast media allergy); or treatment with other immunosuppressive agents within 4 weeks.
•5. Use of immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days prior to the first dose of study treatment.
•6. Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment.
•7. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

Key Dates

Start Date

December 20, 2025

Primary Completion Date

December 30, 2027

Completion Date

December 30, 2028

Last Updated

December 17, 2025

Enrollment

ESTIMATED participants

Conditions

SCLC,Extensive Stage

Interventions

IBI363（PD-1/IL-2a-bias）

DRUG

Contacts

Xiaorong Dong, Ph.D.

CONTACT

+86 13986252286 xhzzdxr@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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