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Trial Title:
Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy
NCT ID:
NCT06332950
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Small Cell Lung Carcinoma
Irinotecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab, Irinotecan Liposome (II)
Description:
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).
Arm group label:
Adebrelimab plus Irinotecan Liposome (II)
Intervention type:
Drug
Intervention name:
Adebrelimab, Irinotecan Liposome (II), Famitinib
Description:
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.
Arm group label:
Adebrelimab plus Irinotecan Liposome (II) and Famitinib
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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:
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.
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.
3. Renal function: Serum creatinine≤1.5×ULN or creatinine clearance≥50ml/min
(Cockcroft-Gault formula).
4. Normal coagulation function: INR and APTT≤1.5×ULN.
5. TSH≤ULN.
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).
7. 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.
Exclusion Criteria:
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Baohui Han, M.D
Email:
18930858216@163.com
Start date:
April 1, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Baohui Han
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06332950