Extensive-stage Small-cell Lung CancerPhase 1/2NCT06332950
Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy
A Phase 1/2 study testing Adebrelimab, Irinotecan Liposome (II) and Adebrelimab, Irinotecan Liposome (II), Famitinib in people with Extensive-stage Small-cell Lung Cancer, run by Baohui Han at 1 site in China.
Trial summary
This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Adebrelimab, Irinotecan Liposome (II) and Adebrelimab, Irinotecan Liposome (II), Famitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Apr 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate and sign the informed consent form.
- Age: 18-75 years old, male or female.
- ECOG PS: 0-1 points.
- Histologically or cytologically confirmed of extensive stage small cell lung cancer (according to the International Association for the Study of Lung Cancer, 8th Edition or VALG II staging system).
- Progression after first-line immunotherapy combined with platinum-based system therapy more than 90 days.
- At least one measurable lesion (RECIST 1.1 criteria) was assessed by imaging evaluation (enhanced CT or MRI) within 4 weeks prior to enrollment.
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- Patients with asymptomatic or treatment-stabilized central nervous system (CNS) metastases must meet the following conditions: (1) No imaging progress for at least 4 weeks after the end of treatment; (2) completion of treatment 4 weeks before enrollment; (3) no treatment with systemic corticosteroids (>10mg/ day prednisone or other equivalent dose) within the first 2 weeks before enrollment.
- Expected survival time ≥12 weeks.
- Adequate hematology and organ function (No blood transfusion or blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days), including:
- Complete blood count: White blood cell count WBC≥3.0×109/L; Absolute neutrophil count ANC≥1.5×109/ L; Platelet count≥100×109/ L; Hemoglobin≥90 g/L.
- Liver function: AST≤2.5× upper limit of normal(ULN); ALT≤2.5×ULN (Patients with liver metastasis, AST and ALT≤5×ULN); TBIL≤1.5×ULN (Except for Gilbert syndrome ≤3×ULN); ALB≥30.0 g/L.
- Renal function: Serum creatinine≤1.5×ULN or creatinine clearance≥50ml/min (Cockcroft-Gault formula).
- Normal coagulation function: INR and APTT≤1.5×ULN.
- TSH≤ULN.
- Other: Lipase≤1.5×ULN (Patients with lipase>1.5×ULN but no clinical or imaging evidence of pancreatitis could be enrolled); Amylase≤1.5×ULN (Patients with amylase >1.5×ULN but no clinical or imaging evidence of pancreatitis could be enrolled); ALP≤2.5×ULN (Patients with bone metastasis, ALP≤5×ULN).
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)≥50%.
- Women of childbearing potential must undergo a negative pregnancy test (HCG) 7 days prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 3 months after the administration of the last therapeutic dose.
Who cannot join
- Non-small cell lung cancer or non-small cell lung cancer admixed with components of small cell lung cancer, as confirmed by histology or cytology.
- With > 2 lines of prior chemotherapy.
- Patients previously treated with topoisomerase I inhibitors.
- With primary resistance, defined as patients who do not respond to first-line treatment or progress within 90 days after the end of treatment.
- Patients previously treated with antiangiogenic drugs, such as bevacizumab, recombinant human endostatin, anlotinib, apatinib, etc.
- Radiotherapy for the chest and whole brain was completed within 4 weeks prior to enrollment (enrollment was allowed if palliative radiotherapy for bone lesions could complete before the first dose).
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- Except for alopecia and fatigue, toxicity due to previous antitumor therapy did not recover to CTCAE 5.0≤1 level before enrollment. Other toxicities due to previous antitumor therapy are not expected to resolve and have long-lasting sequelae.
- With active brain metastasis or meningeal metastasis. Compressive myelopathy that has not been cured or alleviated after surgery and/or radiotherapy, or present with compressive paraplegia or paraplegia after treatment in patients previously diagnosed with compressive myelopathy. Patients with liver metastases had significant clinical symptoms and abnormal liver function after cryotherapy and radiofrequency ablation treatment within the first 4 weeks of enrollment. Patients with uncontrolled mass pleural effusion, pericardial effusion, or ascites. Patients with cardiovascular disease.
- Patients previously treated with systemic immunosuppressive medications within 4 weeks before enrollment.
- Presence or history of active autoimmune disease. Interstitial pneumonia, drug-induced pneumonia, radiation pneumonia requiring steroid treatment (greater than 10 mg/day prednisone or its equivalent), or active pneumonia with clinical symptoms.
- Patients with an active or uncontrolled severe infection (CTCAE 5.0≥2) within 2 weeks prior to the first dose.
- With active tuberculosis or tuberculosis under treatment.
- Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection. Untreated active hepatitis B (HBsAg positive or HBV DNA≥500 IU/ml with abnormal liver function), hepatitis C (hepatitis C antibody positive, with higher HCV-RNA than the lower detection limit of the assay method and abnormal liver function) or hepatitis B and C co-infection.
- Hypertension that cannot be controlled with medications (systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg). History of hypertensive crisis or hypertensive encephalopathy.
- Arteriovenous thrombosis events occurred within 24 weeks prior to signing the ICF, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- With factors influencing absorption of drug, such as refractory nausea and vomiting, chronic gastrointestinal diseases, or inability to swallow the formulated product.
- With mental illness, alcoholism, inability to quit smoking, drug or substance abuse.
- With known allergic history of the drug components of this program, or allergic to other monoclonal antibodies.
- Received any other investigational treatment or participated in any other interventional clinical trials within 4 weeks prior to signing the ICF.
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
Shanghai Chest Hospital
Shanghai
Baohui Han, M.D, 18930858216@163.com
About this study
Official title: A Randomized, Multi-cohort, Multi-center Phase Ib/II Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)
This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).
Read the detailed description
This study is divided into two stages. Dose exploration will be conducted first, and after obtaining preliminary safety data it will be decided by investigator when to proceed with dose extension. The aim of this study is to observe and evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Adebrelimab, Irinotecan Liposome (II), Adebrelimab, Irinotecan Liposome (II), Famitinib
- 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.
Adebrelimab, Irinotecan Liposome (II)Drug
Adebrelimab:1200 mg, IV, D1, Q3W
Irinotecan Liposome (II): RP2D, IV, D1, Q3W
Escalating doses to determine recommended phase 2 dose (RP2D) of Irinotecan Liposome (II).
Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II).
Adebrelimab, Irinotecan Liposome (II), FamitinibDrug
Adebrelimab:1200 mg, IV, D1, Q3W
Irinotecan Liposome (II): RP2D, IV, D1, Q3W
Famitinib: RP2D, QO, QD
Escalating doses to determine recommended phase 2 dose (RP2D) of Famitinib.
Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II) and Famitinib.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab plus Irinotecan Liposome (II) | Experimental | Adebrelimab: 1200 mg, IV, D1, Q3W
Irinotecan Liposome (II): RP2D, IV, D1, Q3W Receives: Drug: Adebrelimab, Irinotecan Liposome (II) |
| Adebrelimab plus Irinotecan Liposome (II) and Famitinib | Experimental | Adebrelimab: 1200 mg, IV, D1, Q3W
Irinotecan Liposome (II): RP2D, IV, D1, Q3W
Famitinib: RP2D, QO, QD Receives: Drug: Adebrelimab, Irinotecan Liposome (II), Famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival
Proportion of disease progression or death from randomization to 6 months of treatment.
Measured: Up to 6 months
Secondary outcomes (6)
Safety
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: Up to 3 months after the last dose
Objective response rate
Objective response rate, determined according to RECIST v1.1 criteria.
Measured: Up to 36 months
Progression-free survival
Progression Free Survival, determined according to RECIST v1.1 criteria.
Measured: Up to 36 months
Overall survival
Overall survival is the time from randomization to death due to any reason or loss of follow-up.
Measured: Up to 36 months
Disease control rate
Disease Control Rate, determined according to RECIST v1.1 criteria.
Measured: Up to 36 months
Duration of response
Duration of Response, determined according to RECIST v1.1 criteria.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baohui Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baohui Han, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332950
- Sponsor's protocol ID
- MA-SCLC-II-015
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-cohort, Multi-center Phase Ib/II Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)
- ClinicalTrials.gov ID
- NCT06332950
- Acronym / sponsor ID
- MA-SCLC-II-015
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Baohui HanUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Mar 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 is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).
Detailed description
This study is divided into two stages. Dose exploration will be conducted first, and after obtaining preliminary safety data it will be decided by investigator when to proceed with dose extension. The aim of this study is to observe and evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab plus Irinotecan Liposome (II) | Experimental | Drug: Adebrelimab, Irinotecan Liposome (II)Adebrelimab: 1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W |
| Adebrelimab plus Irinotecan Liposome (II) and Famitinib | Experimental | Drug: Adebrelimab, Irinotecan Liposome (II), FamitinibAdebrelimab: 1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Famitinib: RP2D, QO, QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Willing to participate and sign the informed consent form.
- Age: 18-75 years old, male or female.
- ECOG PS: 0-1 points.
- Histologically or cytologically confirmed of extensive stage small cell lung cancer (according to the International Association for the Study of Lung Cancer, 8th Edition or VALG II staging system).
- Progression after first-line immunotherapy combined with platinum-based system therapy more than 90 days.
Key exclusion criteria (19 listed)
- Non-small cell lung cancer or non-small cell lung cancer admixed with components of small cell lung cancer, as confirmed by histology or cytology.
- With > 2 lines of prior chemotherapy.
- Patients previously treated with topoisomerase I inhibitors.
- With primary resistance, defined as patients who do not respond to first-line treatment or progress within 90 days after the end of treatment.
- Patients previously treated with antiangiogenic drugs, such as bevacizumab, recombinant human endostatin, anlotinib, apatinib, 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 |
|---|---|---|
| Adebrelimab, Irinotecan Liposome (II)Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Escalating doses to determine recommended phase 2 dose (RP2D) of Irinotecan Liposome (II). Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II). | Drug | Adebrelimab plus Irinotecan Liposome (II) |
| Adebrelimab, Irinotecan Liposome (II), FamitinibAdebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Famitinib: RP2D, QO, QD Escalating doses to determine recommended phase 2 dose (RP2D) of Famitinib. Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II) and Famitinib. | Drug | Adebrelimab plus Irinotecan Liposome (II) and Famitinib |
Primary outcome
6-month progression-free survival
Time frame: Up to 6 months
Proportion of disease progression or death from randomization to 6 months of treatment.
6 secondary outcomes
Safety
Time frame: Up to 3 months after the last dose
Objective response rate
Time frame: Up to 36 months
Progression-free survival
Time frame: Up to 36 months
Overall survival
Time frame: Up to 36 months
Disease control rate
Time frame: Up to 36 months
Duration of response
Time frame: Up to 36 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 27 Mar 2024.
- 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 1/2 study testing Adebrelimab, Irinotecan Liposome (II) and Adebrelimab, Irinotecan Liposome (II), Famitinib in people with Extensive-stage Small-cell Lung Cancer, run by Baohui Han 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 17 inclusion and 19 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 27 Mar 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 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 Baohui Han, M.D (18930858216, 18930858216@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival (time frame: Up to 6 months). 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 27 Mar 2024.