Study in patients with untreated extensive-stage small cell lung cancer with carboplatin or cisplatin plus etoposide with Atezolizumab
- Conditions
- First-line treatment for extensive-stage small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002784-10-ES
- Lead Sponsor
- Roche Farma S.A. (Soc. Unipersonal)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
•Male or female, 18 years of age or older
•ECOG 0-2
•Histologically or cytologically confirmed ES-SCLC
•No prior systemic treatment for ES-SCLC
•Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of extensive-stage SCLC
•Measurable disease, as defined by RECIST v1.1
•Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment
• A pre-treatment tumor tissue sample must be submitted when available
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of study treatment
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
•Active or untreated symptomatic CNS metastases which do not fulfill the inclusion criteria as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
•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 enrollment
•Leptomeningeal disease
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•Uncontrolled or symptomatic hypercalcemia
Patients who are receiving denosumab prior to enrollment must be willing and eligible to discontinue its use and replace it with a bisphosphonate while in the study.
•Malignancies other than SCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Women who are pregnant, lactating, or intending to become pregnant during the study
•History of autoimmune disease are allowed if controlled and on stable treatment for the last 12 weeks
•History of idiopathic pulmonary fibrosis, organizing pneumonia drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest CT scan
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test result at screening) or hepatitis C virus (HCV)
•Active tuberculosis
•Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
•Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
•Major surgical procedure other than for diagnosis within 28 days prior to enrollment or
anticipation of need for a major surgical procedure during the course of the study
•Prior allogeneic bone marrow transplantation or solid organ transplant
•Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
•Patients with illnesses or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures
•Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
•Administration of a live, attenuated vaccine within 4 weeks before enrollment or
anticipation that such a live attenuated vaccine will be required during the study
•Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
•Specifically for patients without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to study treatment initiation or anticipated requirement for systemic immunosuppressive medications during the study treatment period
– For patients with CNS metastases, use of prednisone at a dose (or dose equiv
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method