Health conditions
(Fonte di dati: 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 (Fonte di dati: 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
(Fonte di dati: 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
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
17 feb 2014
Inserimento del primo partecipante
21 mag 2014
Stato di reclutamento
Not Recruiting
Titolo scientifico
(Fonte di dati: 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
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional clinical trial of medicinal product
Disegno della sperimentazione
(Fonte di dati: 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
Fase
(Fonte di dati: WHO)
Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Punti finali primari
(Fonte di dati: 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
Punti finali secondari
(Fonte di dati: 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
Contatto per informazioni
(Fonte di dati: WHO)
F. Hoffmann La Roche Ltd.
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Paesi di esecuzione
(Fonte di dati: 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
Contatto per maggiori informazioni sulla sperimentazione
Contatto per informazioni generali
(Fonte di dati: WHO)
Trial Information Support Line-TISL
Grenzacherstrasse 124
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
global.rochegenentechtrials@roche.com
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Trial Information Support Line-TISL
Grenzacherstrasse 124
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
global.rochegenentechtrials@roche.com
Altri numeri di identificazione delle sperimentazioni
Secondary ID (Fonte di dati: WHO)
GO28915
2013-003331-30-AT
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