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.
Age 18 to 75 years (inclusive), male or female.
Histologically confirmed small cell lung cancer (SCLC).
Extensive-stage SCLC refractory to 2 to 3 prior lines of systemic anti-tumor therapy, which must have included PD-1/PD-L1 immunotherapy.
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.
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).
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.
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.
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.
Single group
IBI363（PD-1/IL-2a-bias）
DrugThe 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).
Objective response rate (ORR)
Objective response rate (ORR) is defined as the rate of patients, among all those enrolled,who achieve a best overall response \[complete response (CR) or partial response (PR)\] according to the RECIST v1.1 across all post-enrolment time-points until the end of follow up for disease progression.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of enrolment until documented progression (according to RECIST v1.1) or death if progression is not documented.
overall survival（OS）
Overall Survival (OS) is defined as the time from first dose of study treatment) until death from any cause.
AE
Adverse events (AEs) according to CTCAE v5.0 (any-cause as well as treatment-related) including AEs leading to dose delays and/or interruptions, withdrawal of protocol treatment, and death.
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