Small Cell Lung CancerPhase 2NCT07004712
Efficacy and Biomarkers of the Second-line Treatment of Adebelizumab Combined With Irinotecan Liposome in Advanced Small Cell Lung Cancer
A Phase 2 study testing Adebelizumab combined with irinotecan liposome as second-line therapy in people with Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is an open, single-arm, single-center phase II clinical study, which aims to evaluate the efficacy and safety of adebelizumab combined with irinotecan liposome in the second-line treatment of advanced small cell lung cancer, explore biomarkers to predict the efficacy, and further select the dominant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Adebelizumab combined with irinotecan liposome as second-line therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Sep 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
- 1. Age: 18-75 years old; 2. Small cell lung cancer diagnosed by histology; Compound small cell lung cancer is not allowed; 3. Progress in receiving first-line chemotherapy combined with immunotherapy (including PD-1 inhibitor and PD-L1 inhibitor); 4. According to RECIST 1.1 standard, there is at least one measurable objective lesion; 5.ECOG score 0-1; 6. The functions of important organs meet the following requirements:Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin concentration ≥ 90g/L;Liver function: bilirubin ≤ 1.5× ULN; Aspartate aminotransferase and glutamate aminotransferase ≤2.5×ULN, and AST and ALT ≤ 5× ULN in case of liver metastasis; Total bilirubin ≤1.5 times the upper limit of normal value;Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance rate (CCR) ≥ 60 ml/min; 7. Expected survival > 12 weeks;Patients have good compliance with the planned treatment, can understand the research process of this study and sign a written informed consent.
Who cannot join
- 1. Irinotecan liposome or Irinotecan has been used before; 2. Severe heart and lung diseases, new york Heart Association (NYHA) scores that patients with heart diseases above Grade II (including Grade II); 3. Patients with severe systemic infection or other serious diseases; 4. Patients who are known to be allergic or intolerant to chemotherapy drugs or their accessories; 5. Other malignant tumors have appeared in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 6. Patients of childbearing age during pregnancy or lactation, and those who refused to take appropriate contraceptive measures during this experiment; 7. Have participated in clinical studies of other drugs within 21 days before the first dose of the study drug is given; 8. Combined with active autoimmune diseases and inflammatory diseases; 9. Grade 3-4 immune-related adverse reactions occurred during previous immunotherapy; 10. Symptomatic brain metastasis and meningeal metastasis; 11. Before the first administration, you are receiving long-term systemic corticosteroid therapy with prednisone > 10mg/d or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy. Subjects who need bronchodilators, inhaled or topical steroids or local steroid injections can be included in this study; 12. Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or poor control of serous cavity effusion (poor control is defined as: puncture and drainage are needed twice or more in one month);The researcher judges the patients who are not suitable to participate in this study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking university cancer hospital
Beijing, Haidian, 100142
Yang Wang, MD, +86-010-88197863, xmwangyang@126.com
Yang Wang, MD
About this study
This study is an open, single-arm, single-center phase II clinical study, which aims to evaluate the efficacy and safety of adebelizumab combined with irinotecan liposome in the second-line treatment of advanced small cell lung cancer, explore biomarkers to predict the efficacy, and further select the dominant population in immunotherapy.
In this study, 46 patients with extensive SCLC who had previously received immunotherapy combined with chemotherapy were enrolled. Subjects who met the enrollment conditions will be given adebelizumab combined with irinotecan liposome at the same time. After 4-6 cycles of treatment, if their condition has not progressed, they will be treated with adebelizumab until the disease progresses, toxicity can not be tolerated or other reasons specified in the scheme can be terminated. Subjects who finish the treatment will enter the follow-up period for safety follow-up and survival follow-up.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Adebelizumab combined with irinotecan liposome as second-line therapy
- Keywords
- small cell lung cancer, Adebelizumab combined with irinotecan liposome, second-line immnunotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebelizumab combined with irinotecan liposome as second-line therapyDrug
Adebellizumab: intravenous drip, 1200mg, the infusion time is controlled between 30-60 minutes, and the infusion is completed within 2 hours at most. It is administered on the first day of each cycle and repeated once every 3 weeks.Irinotecan liposome: intravenous drip, 80mg/m2, infusion time of 30 minutes, the first dose of each cycle, repeated once every 3 weeks.After 4-6 cycles of adebelizumab combined with irinotecan liposome treatment, the subjects who did not develop the disease continued to use adebelizumab (1200mg, D1, Q3W) for maintenance treatment until the disease progressed, the toxicity was intolerable, the subjects voluntarily asked to withdraw and the researchers judged that the subjects needed to withdraw from the study.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | adebelizumab and irinotecan liposome Receives: Drug: Adebelizumab combined with irinotecan liposome as second-line therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
It refers to the time from the date when the subjects enter the group to the time when the disease progresses or dies, whichever comes first.
Measured: 0-12months
Secondary outcomes (4)
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
the proportion of subjects who achieve CR or PR as the best tumor remission during treatment.
Measured: through study completion, an average of 1 year
Overall Survival (OS)
The time from the date of admission to the death caused by any cause.
Measured: 0-5years
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion, an average of 2 year
Biomarker
ScRNA-seq was used to detect the puncture tissue samples before treatment, so as to analyze the influence of single cell level immune signal pathway and immune microenvironment on the efficacy of immunotherapy and explore biomarkers to predict the efficacy.
At the same time, the peripheral blood samples were tested by metabonomics before treatment, after 2 cycles of evaluation and when the disease progressed, so as to explore metabolic markers that can predict and dynamically reflect the efficacy of immunotherapy through non-invasive liquid biopsy.
Measured: "Baseline" and "after 2 cycles of treatment"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Wang, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004712
- Sponsor's protocol ID
- SCLC-001
- Status last verified
- Jun 2025
- First submitted
- 13 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Biomarkers of the Second-line Treatment of Adebelizumab Combined With Irinotecan Liposome in Advanced Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07004712
- Acronym / sponsor ID
- SCLC-001
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, Adebelizumab combined with irinotecan liposome, second-line immnunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Jun 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 an open, single-arm, single-center phase II clinical study, which aims to evaluate the efficacy and safety of adebelizumab combined with irinotecan liposome in the second-line treatment of advanced small cell lung cancer, explore biomarkers to predict the efficacy, and further select the dominant population in immunotherapy.
In this study, 46 patients with extensive SCLC who had previously received immunotherapy combined with chemotherapy were enrolled. Subjects who met the enrollment conditions will be given adebelizumab combined with irinotecan liposome at the same time. After 4-6 cycles of treatment, if their condition has not progressed, they will be treated with adebelizumab until the disease progresses, toxicity can not be tolerated or other reasons specified in the scheme can be terminated. Subjects who finish the treatment will enter the follow-up period for safety follow-up and survival follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: Adebelizumab combined with irinotecan liposome as second-line therapyadebelizumab and irinotecan liposome |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age: 18-75 years old; 2. Small cell lung cancer diagnosed by histology; Compound small cell lung cancer is not allowed; 3. Progress in receiving first-line chemotherapy combined with immunotherapy (including PD-1 inhibitor and PD-L1 inhibitor); 4. According to RECIST 1.1 standard, there is at least one measurable objective lesion; 5.ECOG score 0-1; 6. The functions of important organs meet the following requirements:Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin concentration ≥ 90g/L;Liver function: bilirubin ≤ 1.5× ULN; Aspartate aminotransferase and glutamate aminotransferase ≤2.5×ULN, and AST and ALT ≤ 5× ULN in case of liver metastasis; Total bilirubin ≤1.5 times the upper limit of normal value;Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance rate (CCR) ≥ 60 ml/min; 7. Expected survival > 12 weeks;Patients have good compliance with the planned treatment, can understand the research process of this study and sign a written informed consent.
Key exclusion criteria (2 listed)
- 1. Irinotecan liposome or Irinotecan has been used before; 2. Severe heart and lung diseases, new york Heart Association (NYHA) scores that patients with heart diseases above Grade II (including Grade II); 3. Patients with severe systemic infection or other serious diseases; 4. Patients who are known to be allergic or intolerant to chemotherapy drugs or their accessories; 5. Other malignant tumors have appeared in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 6. Patients of childbearing age during pregnancy or lactation, and those who refused to take appropriate contraceptive measures during this experiment; 7. Have participated in clinical studies of other drugs within 21 days before the first dose of the study drug is given; 8. Combined with active autoimmune diseases and inflammatory diseases; 9. Grade 3-4 immune-related adverse reactions occurred during previous immunotherapy; 10. Symptomatic brain metastasis and meningeal metastasis; 11. Before the first administration, you are receiving long-term systemic corticosteroid therapy with prednisone > 10mg/d or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy. Subjects who need bronchodilators, inhaled or topical steroids or local steroid injections can be included in this study; 12. Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or poor control of serous cavity effusion (poor control is defined as: puncture and drainage are needed twice or more in one month);The researcher judges the patients who are not suitable to participate in this study.
- -
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 |
|---|---|---|
| Adebelizumab combined with irinotecan liposome as second-line therapyAdebellizumab: intravenous drip, 1200mg, the infusion time is controlled between 30-60 minutes, and the infusion is completed within 2 hours at most. It is administered on the first day of each cycle and repeated once every 3 weeks.Irinotecan liposome: intravenous drip, 80mg/m2, infusion time of 30 minutes, the first dose of each cycle, repeated once every 3 weeks.After 4-6 cycles of adebelizumab combined with irinotecan liposome treatment, the subjects who did not develop the disease continued to use adebelizumab (1200mg, D1, Q3W) for maintenance treatment until the disease progressed, the toxicity was intolerable, the subjects voluntarily asked to withdraw and the researchers judged that the subjects needed to withdraw from the study. | Drug | experimental arm |
Primary outcome
Progression Free Survival (PFS)
Time frame: 0-12months
It refers to the time from the date when the subjects enter the group to the time when the disease progresses or dies, whichever comes first.
4 secondary outcomes
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
Time frame: 0-5years
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 2 year
Biomarker
Time frame: "Baseline" and "after 2 cycles of treatment"
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 8 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebelizumab combined with irinotecan liposome as second-line therapy in people with Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
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 1 inclusion and 2 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yang Wang, MD (+86-010-88197863, xmwangyang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 0-12months). 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 8 Jun 2025.