Extensive Stage Small Cell Lung CancerPhase 1/2NCT06597513
Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC
A Phase 1/2 study testing auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab in people with Extensive Stage Small Cell Lung Cancer, run by Zhou Chengzhi.
Trial summary
The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2026
- Phase
- Phase 1/2
- 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 (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) classification.
- ES-SCLC dose not received prior systemic treatment.
- History of localized-stage SCLC with prior radiotherapy and chemotherapy, with the requirement for definitive treatment, and a minimum of 6 months interval from the last treatment to diagnosis of ES-SCLC.
- CT or MRI scan ≤28 days prior to the first dose of study medication, with at least one target lesion that has not been irradiated (RECIST v1.1 criteria).
- Male or female patients aged ≥18 and ≤70 years.
- ECOG Performance Status of 0 or 1.
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- Life expectancy ≥12 weeks.
- Adequate organ system function (excluding use of any blood components or growth factors during screening).
- Male or female participants must agree to use appropriate contraception (e.g., intrauterine device, contraceptive pills, or condoms) from the start of the study treatment until 6 months after the last study treatment; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- Subjects voluntarily participate in this study and sign the informed consent form (ICF).
Who cannot join
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Prior treatment with any T-cell co-stimulatory or immune checkpoint inhibitors, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell targeted agents.
- Prior treatment with vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors.
- Symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. For treated brain metastases, the following criteria must be met: no progression on MRI ≥4 weeks post-treatment, completion of treatment ≥28 days before the first dose of study drug, and no need for systemic corticosteroids (\>10 mg/day prednisone or equivalent) ≤14 days before the first dose.
- Hematologic disorders including, but not limited to, lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, or myelodysplastic syndromes.
- Symptomatic third-space fluid accumulation, such as uncontrolled pericardial effusion, pleural effusion, or ascites despite drainage or other treatments.
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- Active, known, or suspected autoimmune diseases. Exceptions include vitiligo, type 1 diabetes, autoimmune thyroiditis with only hormone replacement therapy, or conditions unlikely to relapse without external stimuli.
- Use of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants ≤14 days before the first dose of study drug. Inhaled or topical corticosteroids and adrenal replacement therapy are allowed if no active autoimmune disease.
- Receipt of or planned vaccination with live vaccines ≤4 weeks before the first dose of study drug.
- Interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring corticosteroids, active pneumonia, or severe pulmonary dysfunction.
- Active tuberculosis or history of active tuberculosis ≤48 weeks before screening, regardless of treatment status.
- Toxicities from prior anticancer treatment other than alopecia and fatigue must have resolved to CTCAE v4.03 ≤ Grade 1 before the first dose. Long-term sequelae such as platinum-based neurotoxicity are allowed if anticipated to be stable.
- Imaging (CT or MRI) showing tumor invasion of major vessels, hemoptysis symptoms within 3 months before screening, or daily hemoptysis ≥2.5 mL.
- Minor surgery (including catheter placement) ≤48 hours before the first dose of study drug.
- Current or recent use of aspirin (\>325 mg/day) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function ≤10 days before the first dose.
- Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytics ≤10 days before the first dose. Preventive anticoagulation is allowed.
- Known hereditary bleeding disorders or coagulation dysfunction. Significant bleeding symptoms or clear bleeding tendencies (e.g., gastrointestinal bleeding, bleeding ulcers, baseline stool occult blood ++ or more) within 12 weeks before screening.
- History of thromboembolic events within 24 weeks before signing the ICF, including stroke (including transient ischemic attack, hemorrhagic stroke, or infarction), deep vein thrombosis, or pulmonary embolism.
- Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), hypertensive crises, or history of hypertensive encephalopathy.
- History of gastrointestinal ulcers, perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra-abdominal abscess within 24 weeks before signing the ICF.
- Uncontrolled cardiac symptoms or diseases, including: (1) NYHA Class ≥II heart failure; (2) unstable angina; (3) myocardial infarction within 24 weeks; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Known allergy to study drug or excipients, or a history of severe allergic reactions to any monoclonal antibody.
- Other malignancies within 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell carcinoma, squamous cell carcinoma of the skin, locally excised prostate cancer, or ductal carcinoma in situ with minimal risk of metastasis and expected cure.
- Known psychiatric disorders, alcohol abuse, drug abuse, or substance misuse.
- Positive HBsAg with HBV DNA levels exceeding normal limits (1000 copies/ml or 500 IU/ml), or positive HCV (HCV RNA or HCV Ab indicating acute or chronic infection); known HIV positive or acquired immunodeficiency syndrome (AIDS).
- Uncontrolled or symptomatic hypercalcemia.
- Receipt of any investigational drug or participation in another interventional clinical trial ≤4 weeks before signing the ICF.
- History of allogeneic bone marrow transplantation or solid organ transplantation.
- Use of systemic immunosuppressive drugs ≤2 weeks before randomization.
- History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin, or etoposide.
- Any other factors that, in the investigator\'s judgment, may lead to premature discontinuation of the study, including non-compliance, severe concurrent illness (including psychiatric illness), significant laboratory abnormalities, or factors affecting the safety or data collection.
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 Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer
The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach.
The main questions it aims to answer are:
Read more
Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment?
Participants will:
Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization.
Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles.
If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles.
Finally, participants may enter a maintenance phase with adebrelimab.
Throughout the trial, participants will:
Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab
- Keywords
- Auto-HSCT, Adebrelimab, Dose-Dense Chemotherapy, Etoposide, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auto-HSCT-Supported Dose-Dense Chemotherapy With AdebrelimabDrug
Also called auto-HSCT, Dose-Dense Chemotherapy, Adebrelimab
Induction:
Two 21-day cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1.
Those without disease progression will advance to consolidation treatment.
Consolidation:
Stem cell mobilization with G-CSF will be start when white blood cell count is at its nadir post-chemotherapy.
After recovery, peripheral blood stem cells will be collected via apheresis, evaluated, and cryopreserved if adequate.
Dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 for two 21-day cycles.
Within 48-72 hours after the first cycle, autologous peripheral blood stem cells will be reinfused with G-CSF.
Further consolidation will depend on hematopoietic recovery with standard-dose EC plus adebrelimab 1200 mg on day 1 for four 21-day cycles.
Maintenance:
Adebrelimab 1200 mg every 21 days will be given until disease progression, intolerable toxicity, death, patient withdrawal, or investigator decision.
| Study group | Role | What they receive |
|---|---|---|
| auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab | Experimental | Complete two 21-days cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1, followed by G-CSF for stem cell mobilization. Receive dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive standaed-dose etoposide and carboplatin plus adebrelimab 1200 mg on day 1 for four cycles. Finally, participants may enter a maintenance phase with adebrelimab1200 mg every 21 days. Receives: Drug: auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, detailed descriptions of the events, the onset timing, severity grade, therapeutic interventions undertaken, and the potential correlation with the investigational medication.
Measured: Time Frame: Followed up every 21 days.
Secondary outcomes (3)
Median Progression Free Survival (mPFS)
The time of disease progression or death in 50% of patients according to K-M curve.
Measured: Imaging examination every 6 weeks.
12-months OS rate
The percentage of patients survival in the 12th months according to the K-M curve.
Measured: Followed up by telephone every 2 months
24-months OS rate
The percentage of patients survival in the 24th months according to the K-M curve.
Measured: Followed up by telephone every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive Stage Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, MD, Study director, The First Affiliated Hospital of Guang Zhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597513
- Sponsor's protocol ID
- CROC-24-07
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu M, Guan W, Xie X, Li Z, Qiu G, Lin X, Xie Z, Zhang J, Qin Y, Huang Z, Xu X, Zhou C. Phase I Clinical Trial of Autologous Hematopoietic Stem Cell Transplantation-Supported Dose-Intensified Chemotherapy With Adebrelimab as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. Clin Lung Cancer. 2025 May;26(3):e236-e241. doi: 10.1016/j.cllc.2024.12.013. Epub 2024 Dec 27.
PubMed 39848827
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06597513
- Acronym / sponsor ID
- CROC-24-07
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- Auto-HSCT, Adebrelimab, Dose-Dense Chemotherapy, Etoposide, Carboplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 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.
The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach.
The main questions it aims to answer are:
Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment?
Participants will:
Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization.
Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles.
If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles.
Finally, participants may enter a maintenance phase with adebrelimab.
Throughout the trial, participants will:
Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab | Experimental | Drug: auto-HSCT-Supported Dose-Dense Chemotherapy With AdebrelimabComplete two 21-days cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1, followed by G-CSF for stem cell mobilization. Receive dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive standaed-dose etoposide and carboplatin plus adebrelimab 1200 mg on day 1 for four cycles. Finally, participants may enter a maintenance phase with adebrelimab1200 mg every 21 days. |
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 (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) classification.
- ES-SCLC dose not received prior systemic treatment.
- History of localized-stage SCLC with prior radiotherapy and chemotherapy, with the requirement for definitive treatment, and a minimum of 6 months interval from the last treatment to diagnosis of ES-SCLC.
- CT or MRI scan ≤28 days prior to the first dose of study medication, with at least one target lesion that has not been irradiated (RECIST v1.1 criteria).
- Male or female patients aged ≥18 and ≤70 years.
Key exclusion criteria (31 listed)
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Prior treatment with any T-cell co-stimulatory or immune checkpoint inhibitors, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell targeted agents.
- Prior treatment with vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors.
- Symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. For treated brain metastases, the following criteria must be met: no progression on MRI ≥4 weeks post-treatment, completion of treatment ≥28 days before the first dose of study drug, and no need for systemic corticosteroids (\>10 mg/day prednisone or equivalent) ≤14 days before the first dose.
- Hematologic disorders including, but not limited to, lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, or myelodysplastic syndromes.
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 |
|---|---|---|
| auto-HSCT-Supported Dose-Dense Chemotherapy With AdebrelimabAlso: auto-HSCT, Dose-Dense Chemotherapy, AdebrelimabInduction: Two 21-day cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1. Those without disease progression will advance to consolidation treatment. Consolidation: Stem cell mobilization with G-CSF will be start when white blood cell count is at its nadir post-chemotherapy. After recovery, peripheral blood stem cells will be collected via apheresis, evaluated, and cryopreserved if adequate. Dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 for two 21-day cycles. Within 48-72 hours after the first cycle, autologous peripheral blood stem cells will be reinfused with G-CSF. Further consolidation will depend on hematopoietic recovery with standard-dose EC plus adebrelimab 1200 mg on day 1 for four 21-day cycles. Maintenance: Adebrelimab 1200 mg every 21 days will be given until disease progression, intolerable toxicity, death, patient withdrawal, or investigator decision. | Drug | auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Time Frame: Followed up every 21 days.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0, detailed descriptions of the events, the onset timing, severity grade, therapeutic interventions undertaken, and the potential correlation with the investigational medication.
3 secondary outcomes
Median Progression Free Survival (mPFS)
Time frame: Imaging examination every 6 weeks.
12-months OS rate
Time frame: Followed up by telephone every 2 months
24-months OS rate
Time frame: Followed up by telephone every 2 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 15 Oct 2024.
- Derived from this study: PubMed 39848827Liu M, Guan W, Xie X, Li Z, Qiu G, Lin X, Xie Z, Zhang J, Qin Y, Huang Z, Xu X, Zhou C. Phase I Clinical Trial of Autologous Hematopoietic Stem Cell Transplantation-Supported Dose-Intensified Chemotherapy With Adebrelimab as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer. Clin Lung Cancer. 2025 May;26(3):e236-e241. doi: 10.1016/j.cllc.2024.12.013. Epub 2024 Dec 27.
- 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.
Chengzhi Zhou, MD study director
The First Affiliated Hospital of Guang Zhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab in people with Extensive Stage Small Cell Lung Cancer, run by Zhou Chengzhi.
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 31 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 15 Oct 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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, MD (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: Time Frame: Followed up every 21 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597513, which also lists 1 linked publication.
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 15 Oct 2024.