SCLC,Extensive StagePhase 2NCT07289048
A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression
A Phase 2 study testing IBI363（PD-1/IL-2a-bias） in people with SCLC,Extensive Stage, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC,Extensive Stage
- What is being tested?
- IBI363（PD-1/IL-2a-bias）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
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- Adequate organ function,
- 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.
- Subjects must provide written informed consent before initiating any study-specific procedures.
Who cannot join
- 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.
- Use of immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days prior to the first dose of study treatment.
- Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment.
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- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Adverse events from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v5.0 or the levels specified in the inclusion criteria (with the exception of toxicities deemed not to pose a safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism stable on hormone replacement therapy).
- Untreated brain metastases (subjects with treated brain metastases are eligible if clinically stable for ≥4 weeks prior to the first dose, off steroid therapy for ≥2 weeks, and without significant peritumoral edema on imaging); leptomeningeal metastasis or brainstem metastasis; spinal cord compression (radiologically identified, regardless of symptoms).
- Active infection requiring intravenous anti-infective therapy at the time of screening.
- History of immunodeficiency, including a positive test for human immunodeficiency virus (HIV).
- Active hepatitis B (HBsAg positive and HBV-DNA ≥1000 IU/mL or copies/mL) or active hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal).
- Interstitial lung disease (except for radiation-induced fibrosis not requiring corticosteroid therapy).
- Significant cardiovascular and cerebrovascular disease history
- Active autoimmune disease, or history of autoimmune disease with potential for recurrence (exceptions include well-controlled autoimmune thyroiditis, type I diabetes, vitiligo, childhood atopic dermatitis resolved, psoriasis not requiring systemic therapy in the past 2 years, etc.).
- Prior history of ≥ Grade 3 immune-related adverse event (irAE) or ≥ Grade 2 immune-related myocarditis associated with prior immunotherapy.
- History of other malignancies, except for those cured for ≥2 years, such as non-melanoma skin cancer, localized prostate cancer, or carcinoma in situ (e.g., cervical carcinoma in situ).
- Pleural effusion or ascites requiring therapeutic intervention (subjects with stable effusion not requiring drainage or stable for ≥1 week after drainage may be eligible); pericardial effusion (asymptomatic, minimal effusion not requiring intervention per investigator's assessment is allowed). If intra-cavitary anti-tumor agents were used during drainage, a washout period of at least 5 half-lives or 21 days (whichever is shorter) must be completed prior to the first dose.
- Known history of alcohol or drug dependence.
- History of psychiatric disorders or anticipated poor compliance.
- Pregnancy or lactation.
- Any other condition deemed by the investigator to potentially compromise the subject's safety or compliance, or make the subject unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-Arm, Exploratory Clinical Study of IBI363 in Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Following Progression on Immunotherapy
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
- Being tested
- IBI363（PD-1/IL-2a-bias）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363（PD-1/IL-2a-bias）Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| IBI363（PD-1/IL-2a-bias） | Experimental | Not described Receives: Drug: IBI363（PD-1/IL-2a-bias） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 12 weeks (±7 days) up to 2 years
Secondary outcomes (3)
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.
Measured: Up to approximately 24 months.
overall survival（OS）
Overall Survival (OS) is defined as the time from first dose of study treatment) until death from any cause.
Measured: Up to approximately 24 months.
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.
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC,Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289048
- Sponsor's protocol ID
- ES-SCLC-IIT-01
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Exploratory Clinical Study of IBI363 in Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Following Progression on Immunotherapy
- ClinicalTrials.gov ID
- NCT07289048
- Acronym / sponsor ID
- ES-SCLC-IIT-01
- Conditions
- SCLC,Extensive Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI363（PD-1/IL-2a-bias） | Experimental | Drug: IBI363（PD-1/IL-2a-bias） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (22 listed)
- 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.
- Use of immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days prior to the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | IBI363（PD-1/IL-2a-bias） |
Primary outcome
Objective response rate (ORR)
Time frame: every 12 weeks (±7 days) up to 2 years
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.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 24 months.
overall survival（OS）
Time frame: Up to approximately 24 months.
AE
Time frame: Up to approximately 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI363（PD-1/IL-2a-bias） in people with SCLC,Extensive Stage, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaorong Dong, Ph.D. (+86 13986252286, xhzzdxr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: every 12 weeks (±7 days) up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.