Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 11:29 AM
Study NCT ID:
NCT06332950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584112', 'term': 'irinotecan sucrosofate'}, {'id': 'C584390', 'term': 'famitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month progression-free survival', 'timeFrame': 'Up to 6 months', 'description': 'Proportion of disease progression or death from randomization to 6 months of treatment.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Up to 3 months after the last dose', 'description': 'Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.'}, {'measure': 'Objective response rate', 'timeFrame': 'Up to 36 months', 'description': 'Objective response rate, determined according to RECIST v1.1 criteria.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 36 months', 'description': 'Progression Free Survival, determined according to RECIST v1.1 criteria.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 36 months', 'description': 'Overall survival is the time from randomization to death due to any reason or loss of follow-up.'}, {'measure': 'Disease control rate', 'timeFrame': 'Up to 36 months', 'description': 'Disease Control Rate, determined according to RECIST v1.1 criteria.'}, {'measure': 'Duration of response', 'timeFrame': 'Up to 36 months', 'description': 'Duration of Response, determined according to RECIST v1.1 criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive-stage Small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to participate and sign the informed consent form.\n* Age: 18-75 years old, male or female.\n* ECOG PS: 0-1 points.\n* 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).\n* Progression after first-line immunotherapy combined with platinum-based system therapy more than 90 days.\n* At least one measurable lesion (RECIST 1.1 criteria) was assessed by imaging evaluation (enhanced CT or MRI) within 4 weeks prior to enrollment.\n* 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.\n* Expected survival time ≥12 weeks.\n* 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:\n\n 1. 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.\n 2. 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.\n 3. Renal function: Serum creatinine≤1.5×ULN or creatinine clearance≥50ml/min (Cockcroft-Gault formula).\n 4. Normal coagulation function: INR and APTT≤1.5×ULN.\n 5. TSH≤ULN.\n 6. 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).\n 7. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)≥50%.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* With \\> 2 lines of prior chemotherapy.\n* Patients previously treated with topoisomerase I inhibitors.\n* With primary resistance, defined as patients who do not respond to first-line treatment or progress within 90 days after the end of treatment.\n* Patients previously treated with antiangiogenic drugs, such as bevacizumab, recombinant human endostatin, anlotinib, apatinib, etc.\n* 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).\n* 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.\n* 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.\n* Patients previously treated with systemic immunosuppressive medications within 4 weeks before enrollment.\n* 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.\n* Patients with an active or uncontrolled severe infection (CTCAE 5.0≥2) within 2 weeks prior to the first dose.\n* With active tuberculosis or tuberculosis under treatment.\n* 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.\n* 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.\n* 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.\n* With factors influencing absorption of drug, such as refractory nausea and vomiting, chronic gastrointestinal diseases, or inability to swallow the formulated product.\n* With mental illness, alcoholism, inability to quit smoking, drug or substance abuse.\n* With known allergic history of the drug components of this program, or allergic to other monoclonal antibodies.\n* Received any other investigational treatment or participated in any other interventional clinical trials within 4 weeks prior to signing the ICF.'}, 'identificationModule': {'nctId': 'NCT06332950', 'briefTitle': 'Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'MA-SCLC-II-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adebrelimab plus Irinotecan Liposome (II)', 'description': 'Adebrelimab: 1200 mg, IV, D1, Q3W\n\nIrinotecan Liposome (II): RP2D, IV, D1, Q3W', 'interventionNames': ['Drug: Adebrelimab, Irinotecan Liposome (II)']}, {'type': 'EXPERIMENTAL', 'label': 'Adebrelimab plus Irinotecan Liposome (II) and Famitinib', 'description': 'Adebrelimab: 1200 mg, IV, D1, Q3W\n\nIrinotecan Liposome (II): RP2D, IV, D1, Q3W\n\nFamitinib: RP2D, QO, QD', 'interventionNames': ['Drug: Adebrelimab, Irinotecan Liposome (II), Famitinib']}], 'interventions': [{'name': 'Adebrelimab, Irinotecan Liposome (II)', 'type': 'DRUG', 'description': 'Adebrelimab:1200 mg, IV, D1, Q3W\n\nIrinotecan Liposome (II): RP2D, IV, D1, Q3W\n\nEscalating doses to determine recommended phase 2 dose (RP2D) of Irinotecan Liposome (II).\n\nParticipants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II).', 'armGroupLabels': ['Adebrelimab plus Irinotecan Liposome (II)']}, {'name': 'Adebrelimab, Irinotecan Liposome (II), Famitinib', 'type': 'DRUG', 'description': 'Adebrelimab:1200 mg, IV, D1, Q3W\n\nIrinotecan Liposome (II): RP2D, IV, D1, Q3W\n\nFamitinib: RP2D, QO, QD\n\nEscalating doses to determine recommended phase 2 dose (RP2D) of Famitinib.\n\nParticipants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II) and Famitinib.', 'armGroupLabels': ['Adebrelimab plus Irinotecan Liposome (II) and Famitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Baohui Han, M.D', 'role': 'CONTACT', 'email': '18930858216@163.com'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Baohui Han, M.D', 'role': 'CONTACT', 'email': '18930858216@163.com', 'phone': '18930858216'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baohui Han', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Baohui Han', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}