Actively Recruiting
A Safety and Efficacy Evaluation of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin for Extensive Stage Small Cell Lung Cancer
Led by Guangzhou Institute of Respiratory Disease · Updated on 2024-12-18
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two drug combinations as first-line treatments for extensive stage small cell lung cancer (ES-SCLC). This phase II, randomized, parallel, multicenter study compares irinotecan liposome (II) combined with adebrelimab and carboplatin versus etoposide combined with adebrelimab and carboplatin. The main goal is to measure the 1-year overall survival rate in patients with this condition. Participants receive one of two treatments: one group gets irinotecan liposome (II) with adebrelimab and carboplatin, while the other receives etoposide with adebrelimab and carboplatin. Treatments are given as part of the initial therapy for ES-SCLC. The study tracks patients through these treatments to compare how the combinations work and their safety profiles. During the study, participants undergo regular assessments including survival monitoring, progression-free survival, response rates, disease control, duration of response, and adverse events over periods ranging from one to three years. These evaluations help researchers understand the treatments' impact and safety. The study is sponsored by the Guangzhou Institute of Respiratory Disease and includes adult patients aged 18 to 70 years with confirmed ES-SCLC who meet specific health and organ function criteria.
CONDITIONS
Brief Title
Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to VALG staging
- No previous systemic treatment for ES-SCLC
- At least 6 months since last radiation or chemotherapy treatment
- At least one target lesion not previously irradiated
- Male or female patients aged 18 to 70 years
- ECOG performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function including hematologic, hepatic, renal, and coagulation parameters
- Agreement to use effective contraception during and 6 months after treatment
- Signed informed consent form indicating understanding and voluntary participation
You will not qualify if you...
- Mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)
- Prior treatment with immune checkpoint inhibitors or irinotecan/DNA topoisomerase inhibitors
- Use of strong CYP3A4 inducers or inhibitors shortly before treatment
- Symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression
- Hematologic disorders such as lymphoma, leukemia, multiple myeloma, or aplastic anemia
- Uncontrolled third-space fluid accumulation like pericardial or pleural effusion
- Active or suspected autoimmune disease
- Recent use of corticosteroids or immunosuppressive agents
- Recent live vaccines
- Interstitial lung disease or active pneumonia
- Active or recent tuberculosis
- Unresolved toxicity from prior anticancer therapy
- Recent minor surgery
- Uncontrolled cardiovascular diseases
- Hypersensitivity to study drugs
- Recent other malignancies except certain skin or in situ cancers
- History of psychiatric disorders, substance abuse
- Active hepatitis B, hepatitis C, or HIV infection
- Recent participation in other investigational drug trials
- History of bone marrow or solid organ transplant
- Other factors as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive treatment with either Irinotecan liposome combined with adebrelimab and carboplatin or etoposide combined with adebrelimab and carboplatin for extensive stage small cell lung cancer.
Multiple visits according to treatment cycles
Trial Site Locations
Total: 1 location
1
Guangzhou Institute of Respiratory Disease (Responsible Party)
Guangzhou, Guangzhou, China, 510120
Actively Recruiting
Research Team
C
Chengzhi Zhou, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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