Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy

NCT06332950 | Not Yet Recruiting Phase 1

• 1 other identifier: MA-SCLC-II-015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival

  Proportion of disease progression or death from randomization to 6 months of treatment.

  Up to 6 months

Secondary Outcomes (6)

• Safety

  Up to 3 months after the last dose

• Objective response rate

  Up to 36 months

• Progression-free survival

  Up to 36 months

• Overall survival

  Up to 36 months

• Disease control rate

  Up to 36 months

Study Arms (2)

Adebrelimab plus Irinotecan Liposome (II)

EXPERIMENTAL

Adebrelimab: 1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W

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

Drug: Adebrelimab, Irinotecan Liposome (II), Famitinib

Interventions

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 plus Irinotecan Liposome (II)

Adebrelimab, Irinotecan Liposome (II), Famitinib DRUG

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.

Adebrelimab plus Irinotecan Liposome (II) and Famitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Baohui Han: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

irinotecan sucrosofate; famitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Baohui Han, M.D

CONTACT

18930858216; 18930858216@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)