A study comparing the clinical benefit and side effects of Atezolizumab to docetaxel in patients with lung cancer who have not benefited from platinum-containing cancer drugs.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2013-003331-30-FI
• Date of registration: 18/02/2014
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A study comparing the clinical benefit and side effects of Atezolizumab to docetaxel in patients with lung cancer who have not benefited from platinum-containing cancer drugs.
• Scientific title: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY
• Date of first enrolment: 18/03/2014
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003331-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes 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: yes 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

Argentina, Austria, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann La Roche Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
•Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
•Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment
•Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
•Measurable disease, as defined by RECIST v1.1
•ECOG performance status of 0 or 1
•Life expectancy > 12 weeks
• For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) during the treatment period and to continue its use for 5 months after the last dose of atezolizumab

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 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion criteria:
•Received therapeutic oral or IV antibiotics within 2 weeks prior to randomization
•Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
•Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live attenuated vaccine will be required during the study
•Positive test for HIV
•Untreated or symptomatic central nervous system metastases
•History of autoimmune disease


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

Health Condition(s) or Problem(s) studied

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE
MedDRA version: 19.0 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 Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
Current Sponsor code: MPDL3280A
Other descriptive name: RO5541267
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Trade Name: Docetaxel
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Current Sponsor code: RO-0647746
Other descriptive name: DOCETAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: The primary objective of this study is to determine if Atezolizumab treatment results in superior OS compared with docetaxel treatment in patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen

Secondary Objective: The secondary efficacy objectives of this study are:
- To evaluate the efficacy of atezolizumab compared with docetaxel with respect to antitumor effects as measured by PFS per investigator using RECIST v1.1
- To evaluate the efficacy of atezolizumab compared with docetaxel with respect to antitumor effects as measured by DOR per RECIST v1.1 for responding patients

Primary end point(s): The primary efficacy endpoint for this trial is duration (in months) of OS (overall survival). OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for patients who are not reported as having died at the time of analysis will be censored at the date they were last known to be alive. Patients who do not have post-baseline information will be censored at the date of randomization plus 1 day. The OS analyses will be performed for the PP (Primary Population) at the PAT (Primary Analysis Time) and for the SP (Secondary Population) at the SAT (Secondary Analysis Time).

Timepoint(s) of evaluation of this end point: Time from the date of randomization to the date of death due to any cause

Secondary Outcome(s)

Secondary end point(s): PFS is defined as the time (in months) between the date of randomization and the date of first documented disease progression or
death, whichever occurs first. Disease progression will be determined based on investigator assessment using RECIST v1.1.

Timepoint(s) of evaluation of this end point: Time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first

Secondary ID(s)

2013-003331-30-AT

GO28915

Source(s) of Monetary Support

F. Hoffmann La Roche Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 26/05/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003331-30/results