Clinical Trials Register

Summary
EudraCT Number:	2013-003331-30
Sponsor's Protocol Code Number:	GO28915
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-02-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-003331-30

A.3

Full title of the trial

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

Studio di fase III, in aperto, multicentrico, randomizzato per valutare efficacia e sicurezza di MPDL3280A (anticorpo anti-PD-L1) rispetto a docetaxel in pazienti con carcinoma polmonare non a piccole cellule, dopo fallimento di un regime chemioterapico a base di platino

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study comparing the clinical benefit and side effects of MPDL3280A to docetaxel in patients with lung cancer who have not benefited from platinum-containing cancer drugs.

Studio che confronta l’efficacia e la sicurezza di MPDL3280A (anticorpo anti-PD-L1) rispetto a docetaxel in pazienti con carcinoma polmonare non a piccole cellule, che non hanno beneficiato di farmaci contententi platino.

A.4.1

Sponsor's protocol code number

GO28915

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F. Hoffmann-La Roche Ltd
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	F. Hoffmann La Roche Ltd.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genentech Inc. c/o F. Hoffmann La Roche Ltd.
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.6	E-mail	global.rochegenentechtrials@roche.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	MPDL3280A-RO5541267
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	MPDL3280A
D.3.9.3	Other descriptive name	RO5541267
D.3.9.4	EV Substance Code	SUB126162
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Docetaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited, UK
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate and solvent for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DOCETAXEL
D.3.9.2	Current sponsor code	RO-0647746
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

Carcinoma Polmonare Non a Piccole Cellule (NSCLC) dopo fallimento di un regime a base di platino

E.1.1.1

Medical condition in easily understood language

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10029514
E.1.2	Term	Non-small cell lung cancer NOS
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to determine if MPDL3280A 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

L’obiettivo primario di efficacia del presente studio è di valutare se il trattamento con MPDL3280A ha come effetto un miglioramento della sopravvivenza globale (overall survival, OS) rispetto al trattamento con docetaxel, in pazienti con carcinoma polmonare non a piccole cellule (non-small cell lung cancer, NSCLC) localmente avanzato o metastatico, progrediti durante o dopo il trattamento con un regime a base di platino.

E.2.2

Secondary objectives of the trial

The secondary efficacy objectives of this study are:
- To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to antitumor effects as measured by ORR per investigator using RECIST v1.1
- To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to antitumor effects as measured by PFS per investigator using RECIST v1.1

Gli obiettivi secondari di efficacia del presente studio sono:
- Valutare l’efficacia di MPDL3280A rispetto a docetaxel in termini di objective response rate (ORR) misurata dallo Sperimentatore secondo i Response Evaluation Criteria in Solid Tumors, Versione 1.1 (RECIST v1.1)
- Valutare l’efficacia di MPDL3280A rispetto a docetaxel in termini di progression free survival (PFS) misurata dallo Sperimentatore secondo i Response Evaluation Criteria in Solid Tumors, Versione 1.1 (RECIST v1.1)

E.2.3

Trial contains a sub-study

E.3

Principal 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

• Diagnosi istologicamente o citologicamente documentata di NSCLC localmente avanzato o metastatico (ossia in stadio IIIB non eleggibile per la chemioradioterapia definitiva, in stadio IV o recidivato
• Disponibilità di campioni rappresentativi di tessuto tumorale fissato in formalina e incluso in blocchetti di paraffina (da preferire) o di almeno 15 sezioni tumorali non colorate montate su vetrino con referto istopatologico associato per la valutazione centralizzata. I campioni/le sezioni tessutali devono essere ritenuti valutabili per l’espressione tumorale di PD-L1 prima dell’arruolamento nello studio
• Comparsa di progressione della malattia durante o dopo il trattamento con un precedente regime a base di platino per il NSCLC localmente avanzato, non resecabile/inoperabile o metastatico, oppure comparsa di recidiva della malattia nei 6 mesi successivi al completamento di un regime adiuvante/neoadiuvante a base di platino
• Malattia misurabile secondo la definizione dei criteri RECIST v1.1
• Performance status ECOG 0 o 1
• Aspettativa di vita ≥ 12 settimane

E.4

Principal 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

• Terapia orale o ev con antibiotici nelle 2 settimane precedenti la randomizzazione
• Intervento di chirurgia maggiore nelle 4 settimane precedenti la randomizzazione o previsione della necessità di una procedura chirurgica maggiore durante lo svolgimento dello studio per scopi diversi da quelli diagnostici
• Somministrazione di un vaccino vivo attenuato nelle 4 settimane precedenti la randomizzazione o previsione della necessità di immunizzazione con un vaccino vivo attenuato durante lo svolgimento dello studio
• HIV test positivo

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy outcome measure is OS, defined as the time from randomization to death from any cause.

La misura primaria dell’outcome di efficacia del presente studio è la OS, definita come il tempo dalla randomizzazione al decesso per tutte le cause

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to section E.5.1

E.5.2

Secondary end point(s)

•PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause.

La PFS, definita come il tempo dalla randomizzazione al primo evento di progressione della malattia, determinata dallo sperimentatore utilizzando i criteri RECIST v1.1, o al decesso per tutte le cause

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to section E.5.2.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

France

Greece

Italy

Japan

Austria

Netherlands

New Zealand

Norway

Portugal

Sweden

Argentina

Brazil

Chile

Finland

Germany

Guatemala

Hungary

Korea, Republic of

Spain

Thailand

Mexico

Panama

Poland

Russian Federation

Serbia

Switzerland

Taiwan

Turkey

Ukraine

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last patient, last visit would be four years after the last patient is enrolled.

L’ultima visita dell’ultimo paziente sarà quattro anni dopo che è stato arruolato l’ultimo paziente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

750

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

347

F.4.2.2

In the whole clinical trial

850

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

The Sponsor will evaluate the appropriateness of continuing to provide MPDL3280A to patients assigned to this treatment after evaluating the primary efficacy outcome measure and safety data gathered in the study. These analyses may be conducted prior to completion of the study.

Lo sponsor valuterà se continuare a fornire MPDL3280A ai pazienti ai quali è stato assegnato questo trattamento dopo la valutazione dell'outcome primario di efficacia e i dei dati di sicurezza raccolti nel corso dello studio. Queste analisi potrebbero essere condotte prima della conclusione dello studio.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-02-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-03-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-01-09

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