Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT05091567
Eligibility Criteria:
Inclusion Criteria for the Induction Phase:
* ECOG PS of 0 or 1
* No prior systemic therapy for ES-SCLC
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* Histologically or cytologically confirmed ES-SCLC
* Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
* Measurable disease, as defined by RECIST v1.1
* Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening
Exclusion Criteria for the Induction Phase:
* Presence or history of CNS metastases
* Active or history of autoimmune disease or deficiency
* History of malignancies other than SCLC within 5 years prior to enrollment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Treatment with investigational therapy within 28 days prior to enrollment
Inclusion Criteria for the Maintenance Phase:
* ECOG PS of 0 or 1
* Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
* Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade \<=1
* Adequate hematologic and end-organ function
Exclusion Criteria for the Maintenance Phase:
* Presence or history of CNS metastases
* Receiving consolidative chest radiation
* Severe infection within 2 weeks prior to randomization into the maintenance
* Treatment with therapeutic oral or IV antibiotics at the time of randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05091567
Study Brief:
Protocol Section:
NCT05091567