treatment-naive, extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status with or without asymptomatic brain metastases (stage IV, ECOG=2) 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 10059514 Term: Small cell lung cancer metastatic System Organ Class: 10029104 - Neo
Conditions
Interventions
Trade Name: Tecentriq (R)
Product Name: Atezolizumab
Product Code: L01XC32
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
CAS Number: 1380723-44-3
Current
Sponsors
AIO-Studien-gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent including participation in translational research obtained from the subject prior to performing any protocol-related procedures, including screening evaluations that are not SOC 2. Age = 18 years 3. ECOG 2 4. At least one measurable tumor lesion (according to RECIST1.1) 5. Histologically confirmed small cell lung cancer (SCLC) 6. Stage IV disease (according to UICC8) 7. No active autoimmune disease 8. Adequate organ function defined as: - neutrophil count > 1.5 x 10^9/L - thrombocytes = 100 x 10^9/L - hemoglobin = 9 g/dL - INR = 1.4 or aPTT = 40 sec during the last 7 days before therapy [Subjects under therapeutic anticoagulation are permitted.] - bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Methodological criteria: 1. Any preceding systemic anticancer therapy for SCLC. [Up to one full-cycle-dosing of carboplatin+etoposide chemotherapy within the context of SOC is permitted prior to study treatment.] (Note: Prior treatment for limited stage disease allowed). 2. Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer 3. Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed cell death-ligand 1 (anti-PD-L1), anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 4. Previous treatment in the present study (does not include screening failure). Medical criteria: 5. Symptomatic CNS metastases. [Patients with asymptomatic brain metastases may be included.] 6. Major surgery = 28 days before first dose of study treatment 7. Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: a. known active HBV, HCV or HIV infection [Patients who are HIV-positive are allowed in the trial, so long as they are stable on anti-retroviral therapy, have a CD4 count = 200 cells/µL, and have an undetectable viral load at the time of screening.] b. active tuberculosis c. any other active infection requiring systemic therapy d. history of allogeneic tissue/solid organ transplant e. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of IMP. f. other active malignancy requiring treatment g. clinically significant or symptomatic cardiovascular/cerebrovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrolment Safety criteria: 8. Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). 9. Known hypersensitivity to carboplatin, etoposide or atezolizumab or any of the constituents of the product. 10. Medication that is known to interfere with any of the agents applied in the trial. 11. Any condition or disease which might interfere with the subject´s ability to comply with the study procedures (e.g., dementia) Regulatory and ethical criteria: 12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG]. 13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of carboplatin+etoposide in combination with atezolizumab in treatment-naïve, stage IV SCLC patients with ECOG PS=2 with or without asymptomatic brain metastases;Secondary Objective: - To assess additional efficacy parameters, e.g. PFS, ORR; - to assess the safety and feasibility of adding atezolizumab to carboplatin+etoposide in this patient population; - to assess quality of life and symptom burden in study subjects; - to assess PRO-CTCAE(TM);Primary end point(s): • Overall survival (OS) incl. milestone 1-year OS rate;Timepoint(s) of evaluation of this end point: after approx. 36 months after first patient in after approx. 12 months after last patient in | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (ORR) (RECIST 1.1) • Progression-free survival (PFS) • Safety and tolerability • Quality of life: o EORTC-QLQ-C30 o PRO CTCAE ;Timepoint(s) of evaluation of this end point: after approx. 36 months after first patient in after approx. 12 months after last patient in | — |
Countries
Austria, Germany
Contacts
Public ContactAIO-Studien-gGmbH
AIO-Studien-gGmbH
Outcome results
None listed