First-line treatment for extensive-stage small cell lung cancer MedDRA version: 21.1 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Roche Farma S.A. (Soc. Unipersonal)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to evaluate the safety of atezolizumab + carboplatin or cisplatin + etoposide;Secondary Objective: To evaluate: •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the intent-to-treat (ITT) population as measured by investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the ITT population as measured by overall survival (OS) •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the ITT population as measured by investigator-assessed objective response rate (ORR) according to RECIST v1.1 •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the ITT population as measured by investigator-assessed duration of response (DOR) according to RECIST v1.1 •The PFS rate at 6 months and at 1 year for the ITT population •The OS rate at 6, 12 and 18 months for the ITT population • Time to Treatment Discontinuation (TTD);Primary end point(s): 1.-Nature, severity, duration, frequency and timing of adverse events (AEs) irrespective of chemotherapy backbone choice 2.-Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab + carboplatin or cisplatin + etoposide administration;Timepoint(s) of evaluation of this end point: 1. and 2.- During all clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.- Progression-free survival (PFS) 2.- Overall survival (OS) 3.- Objective response rate (ORR) 4.- Duration of response (DOR) 5.- PFS rate 6.- OS rate 7.- Time to Treatment Discontinuation;Timepoint(s) of evaluation of this end point: 1.- From screening to progression 2.- From screening to death 3.- During all clinical trial 4.- During all clinical trial 5.- In 6 month and 1 year visit 6.-In 6,12 and 18 months visit 7.- From screening to withdrawal visit | — |
Countries
Spain
Contacts
Public ContactInmaculada Bermejo
Roche Farma S.A. (Soc. Unipersonal)
Outcome results
None listed