Small Cell Lung Cancer Extensive StagePhase 2NCT06739928
Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC
A Phase 2 study testing Irinotecan liposome (II) combined with adebrelimab and carboplatin and etoposide combined with adebrelimab and carboplatin in people with Small Cell Lung Cancer Extensive Stage, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- Irinotecan liposome (II) combined with adebrelimab and carboplatin and etoposide combined with adebrelimab and carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system;
- No prior systemic treatment received;
- At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC;
- Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated;
- Male or female patients aged ≥18 and ≤70 years;
- ECOG performance status (PS) score of 0 or 1;
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- Life expectancy of ≥12 weeks;
- Adequate organ function: (1) Hematologic: WBC ≥ 3.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 9.0 g/dL.(2) Hepatic function: AST ≤ 2.5 × ULN, ALT ≤ 2.5 × ULN, liver metastases allowed if ALT and AST ≤ 5 × ULN, TBIL ≤ 1.5 × ULN (except for Gilbert's syndrome, where total bilirubin ≤ 3.0 mg/dL),(3) Renal function: Cr ≤ 1.5 × ULN or CrCl ≥ 50 mL/min, (4) Coagulation: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
- Agreement to use an appropriate contraceptive method from the first dose of the study treatment until 6 months after the last dose of the study treatment. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;
- The patient must have fully understood the study and voluntarily consent to participate by signing the informed consent form (ICF).
Who cannot join
- Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);
- Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;
- Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;
- Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;
- Hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc;
- Clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, or ascites that cannot be controlled by drainage or other treatments;
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- Active, known, or suspected autoimmune disease;
- Use of corticosteroids (doses> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study drug;
- Receipt of live vaccines or planned vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug;
- Interstitial lung disease, drug-induced pneumonia, radiation-induced pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia, or severe pulmonary dysfunction;
- Active tuberculosis or a history of active tuberculosis within 48 weeks prior to screening, regardless of whether it was treated;
- Any toxicity from previous anticancer therapy, that has not resolved to grade ≤1 (according to CTCAE v5.0) prior to the first dose of the investigational drug;
- Underwent a minor surgery (including catheter placement) within 48 hours prior to the first dose of the study drug;
- Presence of uncontrolled cardiovascular symptoms or diseases;
- Hypersensitivity to the investigational drug or its excipients;
- A history of any other malignancy within 5 years prior to the first dose of the study drug, except for adequately treated non-melanoma skin cancer or in situ carcinoma;
- A history of psychiatric disorders, alcohol abuse, drug abuse, or substance misuse;
- HBsAg-positive and HBV DNA levels exceeding the upper limit of normal, or HCV-positive (HCV RNA or HCV Ab indicating acute or chronic infection); a history of HIV-positive status or acquired immunodeficiency syndrome (AIDS);
- Received any other investigational drug or participated in another interventional clinical trial within 4 weeks prior to signing the informed consent form (ICF);
- A history of allogeneic bone marrow transplantation or solid organ transplantation;
- Any other factors as determined by the investigator.
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, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease (Responsible Party)
Guangzhou, Guangzhou, 510120
Chengzhi Zhou, 13560351186, doctorzcz@163.com
About this study
Official title: A Safety and Efficacy Evaluation Study of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC
This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- Irinotecan liposome (II) combined with adebrelimab and carboplatin, etoposide combined with adebrelimab and carboplatin
- Keywords
- ES-SCLC, extensive stage-small cell lung cancer, adebrelimab, Irinotecan liposome (II), zhou chengzhi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome (II) combined with adebrelimab and carboplatinDrug
Irinotecan liposome (II) + adebrelimab + carboplatin
etoposide combined with adebrelimab and carboplatinDrug
etoposide + adebrelimab + carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome (II)+adebrelimab+carboplatin | Experimental | The patient received treatment with Irinotecan liposome (II), adebrelimab, and carboplatin. Receives: Drug: Irinotecan liposome (II) combined with adebrelimab and carboplatin |
| etoposide+adebrelimab+carboplatin | Other | The patient received treatment with etoposide, adebrelimab, and carboplatin. Receives: Drug: etoposide combined with adebrelimab and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year OS rate
The proportion of patients who are still alive after one year of treatment.
Measured: 1 year
Secondary outcomes (6)
Progression-free survival (PFS)
Time from start of patient's treatment to disease progression or death from any cause.
Measured: 1 year
Overall survival (OS)
Time from patient randomization to patient death from any cause.
Measured: 2 years
Objective response rate (ORR)
Proportion of patients whose tumor volume shrinks to a pre-specified value and who can maintain the minimum timeframe requirement, as the sum of the proportion in complete and partial remission.
Measured: 1 year
Disease control rate（DCR）
Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases.
Measured: 1 year
Duration of Response (DoR)
the time between the first time a subject in confirmed complete remission (CR) or confirmed partial remission (PR) reaches confirmed complete remission (CR) or confirmed partial remission (PR) and the time of the first disease progression or death of any cause.
Measured: 1 year
AEs rate
Incidence of adverse events occurring during treatment.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2027 (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 Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, Doctor, Principal investigator, Guangzhou Institute of Respiratory Disease (Responsible Party)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739928
- Sponsor's protocol ID
- ES-2024-209-01
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Evaluation Study of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC
- ClinicalTrials.gov ID
- NCT06739928
- Acronym / sponsor ID
- ES-2024-209-01
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Keywords
- ES-SCLC, extensive stage-small cell lung cancer, adebrelimab, Irinotecan liposome (II), zhou chengzhi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (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, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome (II)+adebrelimab+carboplatin | Experimental | Drug: Irinotecan liposome (II) combined with adebrelimab and carboplatinThe patient received treatment with Irinotecan liposome (II), adebrelimab, and carboplatin. |
| etoposide+adebrelimab+carboplatin | Other | Drug: etoposide combined with adebrelimab and carboplatinThe patient received treatment with etoposide, adebrelimab, and carboplatin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system;
- No prior systemic treatment received;
- At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC;
- Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated;
- Male or female patients aged ≥18 and ≤70 years;
Key exclusion criteria (21 listed)
- Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);
- Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;
- Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;
- Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;
- Hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc;
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 |
|---|---|---|
| Irinotecan liposome (II) combined with adebrelimab and carboplatinIrinotecan liposome (II) + adebrelimab + carboplatin | Drug | Irinotecan liposome (II)+adebrelimab+carboplatin |
| etoposide combined with adebrelimab and carboplatinetoposide + adebrelimab + carboplatin | Drug | etoposide+adebrelimab+carboplatin |
Primary outcome
1-year OS rate
Time frame: 1 year
The proportion of patients who are still alive after one year of treatment.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 1 year
Disease control rate（DCR）
Time frame: 1 year
Duration of Response (DoR)
Time frame: 1 year
AEs rate
Time frame: 3 years.
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 18 Dec 2024.
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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.
Chengzhi Zhou, Doctor principal investigator
Guangzhou Institute of Respiratory Disease (Responsible Party)
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 Irinotecan liposome (II) combined with adebrelimab and carboplatin and etoposide combined with adebrelimab and carboplatin in people with Small Cell Lung Cancer Extensive Stage, run by Guangzhou Institute of Respiratory Disease 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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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 Chengzhi Zhou, Doctor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year OS rate (time frame: 1 year). 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 18 Dec 2024.