No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Other
Who this trial is looking for
This trial is looking for adults with advanced small cell lung cancer that has spread. Participants will receive a combination of a new drug called adebrelimab along with standard chemotherapy and radiation treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with extensive stage small cell lung cancer.
I have 5 or fewer metastatic lesions.
I have not had any previous chemotherapy, radiation, or immunotherapy.
I can provide a tumor tissue sample for testing.
I have an expected survival time of at least 3 months.
I have a good performance status and limited symptoms.
I have adequate blood and organ function.
You may not be able to join if
I have untreated spinal cord compression.
I have leptomeningeal disease.
I have uncontrolled pleural effusion, pericardial effusion, or ascites.
I have uncontrolled hypercalcemia.
I have had another cancer in the last 5 years, except a low-risk type.
I have a history of autoimmune disease.
I have received prior immune checkpoint therapies.
I have significant cardiovascular disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Signed inform consent form
* Age \>= 18 years and \<= 75 years
* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system),the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previ…
Inclusion Criteria:
* Signed inform consent form
* Age \>= 18 years and \<= 75 years
* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system),the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Expected survival time ≥ 3 months
* Patients must submit a pre-treatment tumor tissue sample during the study.
* Adequate hematologic and end organ function
Exclusion Criteria:
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease
* Prior treatment with immune checkpoint blockade therapies
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
* Significant cardiovascular disease
* Prior allogeneic bone marrow transplantation or solid organ transplant
* Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization
* History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Contacts
No contact information available.
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