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: 28 February 2019
• Main ID: EUCTR2014-003205-15-HU
• Date of registration: 19/11/2015
• 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 PATIENTS WITH COMPLETELY RESECTED STAGE IB-IIIA NON-SMALL CELL LUNG CANCER
• Date of first enrolment: 19/11/2015
• Target sample size: 1127
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

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:
- A representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in paraffin block (preferred) or 15 (or more) unstained, freshly cut, serial sections (on slides) 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, T4-N0 1) non-small cell lung cancer (NSCLC)
- Eligible to receive a cisplatin-based chemotherapy regimen
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment that results in a low failure rate of < 1% per year when used consistently and correctly. Female and male patients should continue contraceptive use for 6 months after the last dose of cisplatin-based chemotherapy (cisplatin plus vinorelbine, docetaxel, gemcitabine, or pemetrexed). Female patients treated with atezolizumab should continue contraception use for 5 months after the last dose. Women must refrain from donating eggs during this same period


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 790
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 337

Exclusion criteria:
- Illness or condition that may interfere with a patient’s capacity to understand, follow, and/or comply with study procedures
- Pregnant and lactating women
- Treatment with prior systemic chemotherapy, with the following exceptions:
•Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment, may be allowed upon approval by the Medical Monitor
•Low-dose chemotherapy for non-malignant conditions may be allowed upon 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 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 CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Patients who have had prior anti-CTLA-4 treatment may be enrolled, provided the following requirements are met:
•Last dose of anti-CTLA-4 at least 6 weeks prior to randomization
•No history of severe immune-mediated adverse effects from anti-CTLA-4 (NCI CTCAE Grades 3 and 4)
- Known tumor PD-L1 expression status as determined by an IHC assay from other clinical studies (e.g., patients whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)




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

Health Condition(s) or Problem(s) studied

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

NON-SMALL CELL LUNG CANCER
MedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864

Intervention(s)

Product Name: MPDL3280A-RO5541267
Pharmaceutical Form: Concentrate for 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-

Trade Name: Tecentriq
Pharmaceutical Form: Concentrate for 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)

Timepoint(s) of evaluation of this end point: 1.-Approximately 5 years

Primary end point(s): 1.-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 atezolizumab monotherapy treatment compared with BSC as measured by overall survival (OS) in ITT population; 3-year and 5-year DFS rates in the PD-L1-selected populations within the Stage II-IIIA subpopulation, in all-randomized patients with Stage II-IIIA NSCLC, and in the ITT population and by DFS within the PD-L1-selected populations in the evaluable Stage II-IIIA subpopulation and within the evaluable ITT population

Main Objective: To evaluate the efficacy of atezolizumab monotherapy treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator in PD-L1-selected populations within the Stage II-IIIA subpopulation, in all randomized Stage II–IIIA patients, and in the ITT population

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-3 Approximately 5 years

Secondary end point(s): 1.-OS, defined as the time from randomization to death from any cause
2.-DFS rates at 3 years and 5 years in the PD-L1-selected and all-randomized populations for Stage II-IIIA, and in the ITT population
3.-DFS within the PD-L1-selected populations in the evaluable Stage II-IIIA subpopulation and within the evaluable ITT population

Secondary ID(s)

2014-003205-15-BE

GO29527

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date:
Contact: