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.

• Register: EUCTR
• Last refreshed on: 26 October 2015
• Main ID: EUCTR2014-003205-15-ES
• Date of registration: 15/10/2015
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: 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.
• Scientific title: 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 ADJUVANT CISPLATIN-BASED CHEMOTHERAPY IN PD-L1?SELECTED PATIENTS WITH COMPLETELY RESECTED STAGE IB?IIIA NON?SMALL CELL LUNG CANCER
• Date of first enrolment: 19/10/2015
• Target sample size: 845
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003205-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
?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

Exclusion criteria:
? 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

NON?SMALL CELL LUNG CANCER
MedDRA version: 18.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Atezolizumab
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Primary end point(s): ?DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first:
First recurrence of NSCLC, as determined by the investigator after an
integrated assessment of radiographic data, biopsy sample results (if available),
and clinical status
Occurrence of new primary NSCLC, as assessed by the investigator
Death from any cause

Secondary Objective: To evaluate the efficacy of 16 cycles of atezolizumab treatment compared with BSC as measured by OS

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.

Timepoint(s) of evaluation of this end point: Please refer to E.5.1

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Please refer to E.5.2

Secondary end point(s): ?OS, defined as the time from randomization to death from any cause

Secondary ID(s)

GO29527

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd