Actively Recruiting
Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer After First-line Induction with Adebrelimab Plus Chemotherapy A Multi-center, Single-arm Phase 2 Clinical Trial
Led by Yunpeng Liu · Updated on 2025-01-06
38
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
Sponsors
Y
Yunpeng Liu
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of maintenance therapy combining Adebrelimab with Apatinib in patients with extensive stage small cell lung cancer who have completed initial treatment with Adebrelimab plus chemotherapy. This single-arm, prospective trial focuses on patients diagnosed with this advanced cancer stage, aiming to improve progression-free survival and other clinical outcomes. The study will also explore biomarkers such as immune and hematopoietic factors to support future clinical trials. During the induction phase, participants receive Adebrelimab (1200 mg intravenously on day 1) combined with carboplatin or cisplatin plus etoposide chemotherapy over 4 to 6 cycles every three weeks. In the maintenance phase, they continue with Adebrelimab (1200 mg IV on day 1) alongside daily oral Apatinib (250 mg) in three-week cycles. After disease progression, treatment may continue with tailored combinations of Apatinib, Adebrelimab, and chemotherapy depending on prior platinum sensitivity and progression timelines. Participants undergo regular evaluations including imaging to assess tumor response and progression, laboratory tests, and biomarker studies. The primary measure is progression-free survival up to about six months, with additional outcomes including remission rates, disease control, duration of remission, and overall survival. Safety and tolerability are monitored throughout, with follow-up continuing after disease progression. The study contributes data to inform larger future trials.
CONDITIONS
Official Title
Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily enroll and sign informed consent, agreeing to follow-up visits
- Age 18 years or older, any gender
- Histologically or pathologically confirmed extensive stage small cell lung cancer
- ECOG performance status of 0 to 2
- No prior systemic treatment for extensive stage small cell lung cancer, including chemotherapy, VEGFR inhibitors, or immune checkpoint inhibitors
- Patients with limited stage small cell lung cancer who completed prior treatment more than 6 months ago
- Life expectancy of at least 3 months
- Presence of at least one measurable tumor lesion meeting RECIST 1.1 criteria
- Normal major organ function as defined by specific blood counts and biochemical test thresholds
- Negative pregnancy test for females of childbearing potential within 72 hours before first dose
- Agreement to use effective contraception during study and up to 90 days after last dose for females and males
- Female participants must agree to refrain from breastfeeding during the study and up to 180 days after last dose
You will not qualify if you...
- Presence of meningeal metastases
- Prior treatment with T-cell co-stimulation or immune checkpoint therapies
- Prior treatment with apatinib
- Conditions affecting oral medication intake such as swallowing difficulties or gastrointestinal issues
- Active autoimmune diseases or history of certain autoimmune disorders requiring medical intervention
- Immune deficiencies or active infections including HIV, active hepatitis B or C
- Significant proteinuria or severe liver or kidney dysfunction
- Recent use of systemic corticosteroids or immunosuppressive drugs
- Recent treatment with immunostimulatory antitumor agents
- Other malignancies within 5 years except certain treated localized cancers
- Evidence of lung diseases such as pulmonary fibrosis or active pneumonia
- Uncontrolled high blood pressure
- Recent serious heart conditions or poorly controlled arrhythmias
- Recent severe infections or unexplained fever
- Major surgery, biopsy, or trauma within 28 days before enrollment
- Recent thrombotic events
- High risk of bleeding or perforation
- History of organ or stem cell transplantation
- Pregnancy or lactation, or unwillingness/inability to use contraception
- Known allergies or intolerances to study drugs or their components
- Any condition judged by the investigator to interfere with study participation or safety
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Trial Site Locations
Total: 2 locations
1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Actively Recruiting
2
The First Hospital of China Medical University
Shenyang, China, 110000
Not Yet Recruiting
Research Team
X
Xiujuan Qu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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