EXTENSIVE-STAGE SMALL CELL LUNG CANCER (es-SCLC) 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)
Conditions
Interventions
Trade Name: Tecentriq
Product Name: Atezolizumab
Product Code: [RO5541267]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Atezolizumab
Current Sponsor code: R05541267
Sponsors
ROCHE SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed Informed Consent Form - Age > 18 years at time of signing Informed Consent Form - Ability to comply with the study protocol, in the investigator's judgment - Histologically or cytologically confirmed ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system - Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) from 0 to 2 - Life expectancy > 12 weeks - 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 ES-SCLC - Patients where thoracic radiotherapy (RT) is clinically indicated could be enrolled providing they receive RT between the completion of induction phase and the beginning of maintenance phase - Patients with Paraneoplastic syndromes can be enrolled if an autoimmune origin can be excluded - Adequate hematologic and end organ function Negative human immunodeficiency virus (HIV) test at screening- Negative hepatitis B surface antigen (HBsAg) test at screening - Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening The HBV DNA test will be performed only for patients who have a positive total HBcAb test. - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test will be performed only for patients who have a positive HCV antibody test. - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraception For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Symptomatic or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium >12 mg/dL or corrected calcium >ULN) - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Active tuberculosis - Significant cardiovascular disease, (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study - History of malignancy other than SCLC within 5 years prior to screening, with exceptions - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. - Prior allogeneic stem cell or solid organ transplantation - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications - Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab - Current treatment with anti-viral therapy for HBV - Treatment with investigational therapy within 28 days prior to initiation of study treatment Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti¿CTLA-4, anti¿PD-1, and anti¿PD-L1 therapeutic antibodies - Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment - Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti -TNF- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with exceptions History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation - Known allergy or hypersensitivity to car
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to evaluate the safety of atezolizumab in combination with carboplatin plus etoposide in patients with untreated extensive-stage small cell lung cancer (SCLC).;Secondary Objective: Main secondary objective is to evaluate the efficacy of combination on the basis of the following endpoint: Overall survival (OS) rate at 1and2 years, defined as the proportion of patients remaining alive at 1and2 years after initiation of study treatment. Other secondary objective is based on the following endpoint: - OS, defined as the time from initiation of study treatment to death from any cause; - Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. Calculated according to RECIST v1.1. - Objective response rate (ORR), defined as the % of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1; - Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Calculated according to RECIST v1.1.;Primary end point(s): -Incidence of serious adverse events (SAEs) related to atezolizumab in combination with carboplatin plus etoposide treatment - Incidence of serious and non-serious immune-related adverse events (irAEs) related to atezolizumab in combination with carboplatin plus etoposide treatment;Timepoint(s) of evaluation of this end point: The primary analysis of the safety endpoints will be undertaken once all patients have completed the study treatment phase and safety follow-up (4 weeks after their last dose of study treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Overall survival (OS) rate at 1 year and 2 years, defined as the proportion of patients remaining alive at 1 and 2 years after initiation of study treatment. OS, defined as the time from initiation of study treatment to death from any cause - Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) - Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1. - Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.;Timepoint(s) of evaluation of this end point: The primary analysis of the safety endpoints will be undertaken once all patients have completed the study treatment phase and safety follow-up (4 weeks after their last dose of study treatment). | — |
Countries
Italy
Contacts
Public ContactMedical Affairs&Clinical Operations
Roche SpA
Outcome results
None listed