Actively Recruiting
Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC
Led by Qianfoshan Hospital · Updated on 2023-11-09
51
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe the efficacy and safety of adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy in the treatment of newly diagnosed extensive small cell lung cancer.
CONDITIONS
Official Title
Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Diagnosed with extensive small cell lung cancer confirmed by histology or cytology, including certain metastases
- ECOG performance status of 0 or 1
- No prior first-line systemic therapy or immune checkpoint inhibitor treatment for extensive small cell lung cancer
- Previous surgery did not include adjuvant chemotherapy or radiotherapy, with at least 6 months since last treatment
- Able to provide tumor tissue samples taken within 6 months before first study drug dose
- Estimated survival time of at least 8 weeks
- Presence of measurable lesion by RECIST v1.1 criteria
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Agrees to use contraception during the study and for 24 weeks after last dose
- Laboratory test values meet specified blood, liver, kidney, coagulation, and enzyme criteria
- Voluntary informed consent and ability to comply with study procedures
You will not qualify if you...
- Symptomatic brain metastasis or liver metastasis
- Recurrent symptomatic effusions requiring repeated drainage
- Uncontrolled or symptomatic high blood calcium levels
- Other cancers within 5 years except certain localized or treated cancers
- Active or suspected autoimmune diseases, with specific exceptions
- Recent use of systemic immunosuppressants or corticosteroids above 10 mg prednisone equivalent
- Prior immune checkpoint or T cell co-stimulation therapies
- Positive for hepatitis B with high viral load, hepatitis C, HIV, or AIDS
- History of severe lung diseases or active infections including tuberculosis
- Serious infections requiring hospitalization
- Major surgery within 28 days before study or planned during study
- Use of live attenuated vaccines near study enrollment or during study
- Serious cardiovascular disease or recent cardiac events
- Previous allogeneic bone marrow or solid organ transplant
- Known allergy to study drugs or monoclonal antibodies
- Participation in another trial or experimental drug within 4 weeks before consent
- Mental illness, substance abuse, or other factors affecting compliance or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jiandong Zhang
CONTACT
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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