A PHASE III, OPEN-LABEL, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH BEST SUPPORTIVE CARE FOLLOWING LUNG CANCER RESECTION AND CHEMOTHERAPY FOR EARLY STAGE LUNG CANCER.
- Conditions
- ON-SMALL CELL LUNG CANCERMedDRA version: 18.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003205-15-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 845
•Tumor PD-L1 expression of TC3 or IC3, as determined by an IHC assay performed by a central laboratory on a resected tumor tissue previously obtained at screening. A representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in paraffin block (preferred) or a minimum of 15 unstained, freshly cut, serial sections from an FFPE resected tumor specimen is required for participation in
this study. This specimen must be accompanied by the associated pathology report.
•ECOG performance status of 0 or 1
•Histological or cytological diagnosis of Stage IB (tumors = 4 cm)-IIIA (T2-3 N0, T1-3 N1, T1-3 N2) NSCLC
•Eligibility to receive a cisplatin-based chemotherapy regimen
•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 90 days after the last dose of study drug
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 592
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245
• Pregnant and lactating women
•Treatment with prior systemic chemotherapy at any time
Methotrexate given in low doses for non-malignant conditions with the last dose
at least 14 days prior to date of enrollment will be allowed. Other low-dose
chemotherapeutics for non-malignant conditions will be considered after
discussion with and approval by the Medical Monitor
•Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
•Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
•Known sensitivity to any component of the chemotherapy regimen the patient will be assigned to, or to mannitol
•Prior treatment with an anti-PD-1, anti-PD-L1, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of 16 cycles of atezolizumab treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator.<br>;Secondary Objective: To evaluate the efficacy of 16 cycles of atezolizumab treatment compared with BSC as measured by OS;Primary end point(s): •DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first:<br>First recurrence of NSCLC, as determined by the investigator after an<br>integrated assessment of radiographic data, biopsy sample results (if available),<br>and clinical status<br>Occurrence of new primary NSCLC, as assessed by the investigator<br>Death from any cause;Timepoint(s) of evaluation of this end point: Please refer to E.5.1
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •OS, defined as the time from randomization to death from any cause;Timepoint(s) of evaluation of this end point: Please refer to E.5.2