Health conditions
(Datenquelle: WHO)
NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE
MedDRA version: 19.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions (Datenquelle: WHO)
Product Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Atezolizumab
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
INN or Proposed INN: DOCETAXEL
Current Sponsor code: RO-0647746
Other descriptive name: DOCETAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Inclusion/Exclusion Criteria
(Datenquelle: WHO)
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
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Weitere Informationen zur Studie
Datum der Studienregistrierung
17.02.2014
Einschluss der ersten teilnehmenden Person
21.05.2014
Rekrutierungsstatus
Not Recruiting
Wissenschaftlicher Titel
(Datenquelle: WHO)
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
Studientyp
(Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie
(Datenquelle: WHO)
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
(Datenquelle: WHO)
Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Primäre Endpunkte
(Datenquelle: WHO)
Timepoint(s) of evaluation of this end point: Time from the date of randomization to the date of death due to any cause;
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).
;
Secondary Objective: The secondary efficacy objectives of this study are:
- To evaluate efficacy of atezolizumab compared with docetaxel with respect to anti-tumor 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 ORR per investigator using RECIST v1.1
- To evaluate efficacy of atezolizumab compared with docetaxel with respect to anti-tumor effects as measured by DOR per RECIST v1.1 for responding patients
;
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
Sekundäre Endpunkte
(Datenquelle: WHO)
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
Kontakt für Auskünfte
(Datenquelle: WHO)
F. Hoffmann La Roche Ltd.
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: WHO)
Argentina, Austria, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Republic of, Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Trial Information Support Line-TISL
Grenzacherstrasse 124
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
global.rochegenentechtrials@roche.com
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Trial Information Support Line-TISL
Grenzacherstrasse 124
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
global.rochegenentechtrials@roche.com
Weitere Studienidentifikationsnummern
Secondary ID (Datenquelle: WHO)
GO28915
2013-003331-30-AT
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