Small Cell Lung Cancer MedDRA version: 19.0 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 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: 19.0 Level: PT Classification code 10041069 Term: Small cell lung
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: Etoposide
Other descriptive name: ETOPOSIDE
Pharmaceutical Form:
INN or Proposed INN: Carboplatin
Other descriptive name: CARBOPLATIN
Pharmaceutical Form:
Sponsors
IFCT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed small-cell lung cancer. 2. Extensive or limited disease according to the criteria of the Veteran's Administration Lung Cancer Group: (disease extended is defined as a disease beyond hemi thorax and supraclavicular lymph node areas. Tumor pleural effusion will be considered as extended disease). 3. Targetable tumor lesions according to RECIST 1.1. Tumor involvement encompassed into a radiotherapy field is eligible as target pending that progression is documented. 4. 6 slides of tumor tissue or paraffin block sent to IFCT for PD-L1 immunohistochemistry 5. Previous platinum – etoposide treatment for at least 2 cycles. 6. Demonstrated progression of the disease other than brain metastasis or carcinomatous meningitis. 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Non-small cell lung cancer or mixed small-cell lung cancer - non small cell cancer. 2. Prior immunotherapy 3. Documented progression of cerebral metastases (whatever symptomatic or not) or carcinomatous meningitis. 4. Corticosteroid with a dose over 10 mg prednisolone or equivalent for more than 10 days during the previous month. 14. Systemic immunosuppressive therapy (eg cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor [TNF]) during the two weeks preceding the day 1 of cycle 1. 15. Auto-immune disease History of autoimmune disease, including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, syndrome Guillain-Barré, multiple sclerosis, vasculitis or glomerulonephritis. Patients with a history of hypothyroidism origin autoimmune treated with a stable dose replacement therapy may be eligible for this study. Patients with controlled type 1 diabetes treated with insulin are eligible in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity of anti-PDL1 antibody ATEZOLIZUMAB (MPDL3280A) in second line after progression following platinum – etoposide regimen Phase II component of the study ;Secondary Objective: Duration of response Progression-free survival Overall survival Quality of life (EQ5D – LCSS) Safety – AE (NCI –CTC 4.0) Reponses rate according to tissue PD-L1 expression ;Primary end point(s): Response rate in the experimental arm;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival • Progression-free survival • Response rate in the experimental arm as assessed by panel • Response rate (in the control arm) • Duration of response • Quality of life (LCSS) • Safety – AE (NCI –CTC v4.0) • Reponses rate according to tissue PD-L1 expression: PD-L1 expression status will be determined according to IHC (Ventana and Dako antibodies) and qRT-PCR criteria.;Timepoint(s) of evaluation of this end point: - Time from randomization until death due to any cause. - Time from randomization to first observation of progression or date of death (from any cause). - 6 weeks - 6 weeks - Time from documentation of tumor response to disease progression - During study treatment - During study treatment | — |
Countries
France
Contacts
Public ContactContact
IFCT
Outcome results
None listed