Clinical Trials Register

Summary
EudraCT Number:	2020-000556-35
Sponsor's Protocol Code Number:	D910LC00001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-06-30
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2020-000556-35

A.3

Full title of the trial

A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)

Wieloośrodkowe badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające skuteczność terapii adjuwantowej z wykorzystaniem durwalumabu w połączeniu z chemioterapią opartą na pochodnych platyny w leczeniu pacjentów z niedrobnokomórkowym rakiem płuc w II i III stopniu zaawansowania po kompletnej resekcji (MERMAID-1)

A.3.1

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

Phase III study to determine the efficacy of Durvalumab in combination with chemotherapy in completely resected stage II-III non-small cell lung cancer.

Badanie fazy III oceniające skuteczność terapii durwalumabem w połączeniu z chemioterapią opartą na pochodnych platyny w leczeniu pacjentów z niedrobnokomórkowym rakiem płuc w II i III stopniu zaawansowania po kompletnej resekcji

A.3.2

Name or abbreviated title of the trial where available

MERMAID-1

A.4.1

Sponsor's protocol code number

D910LC00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	MedImmune Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	Karlebyhus, Astraallén
B.5.3.2	Town/ city	Södertälje
B.5.3.3	Post code	151 85
B.5.3.4	Country	Sweden
B.5.6	E-mail	information.center@astrazeneca.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.3.1	Product name	Durvalumab
D.3.2	Product code	MEDI4736
D.3.4	Pharmaceutical form	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	Durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
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	50
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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Completely Resected Stage II-III NSCLC

Niedrobnokomórkowy rak płuca (NDRP) w II i III stadium zaawansowania po kompletnej resekcji

E.1.1.1

Medical condition in easily understood language

Specific type of lung cancer called “Non-Small Cell Lung Cancer” at specific stage (stage II/III)

Specyficzny typ raka płuc o nazwie „niedrobnokomórkowy rak płuca” na szczególnym etapie zaawansowania choroby (stadium II/III)

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in all patients.

Ocena skuteczności durwalumabu w skojarzeniu z chemioterapią SoC w porównaniu z placebo w skojarzeniu z chemioterapią SoC, mierzona długością czasu przeżycia wolnego od choroby (DFS), na podstawie oceny badacza, u wszystkich pacjentów

E.2.2

Secondary objectives of the trial

1. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using Investigator assessments according to RECIST 1.1 in MRD+ patients.
2. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by OS in MRD+ patients and in all patients

1. Ocena skuteczności durwalumabu w skojarzeniu z chemioterapią SoC w porównaniu do placebo w skojarzeniu z chemioterapią SoC, mierzona długością DFS, na podstawie oceny badacza, u wszystkich pacjentów
2. Ocena skuteczności durwalumabu w skojarzeniu z chemioterapią SoC w porównaniu z placebo w skojarzeniu z chemioterapią SoC, mierzona długością OS u pacjentów MRD+ oraz u wszystkich pacjentów

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Capable of giving signed informed consent, which includes a mandatory
genetic informed consent and compliance with the requirements and restrictions listed in the
informed consent forms (ICFs) and study protocol
2. Age ≥18 years at the time of screening
3. Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease
4. Complete resection of the primary NSCLC

1. Pacjenci muszą być w stanie wyrazić świadomą zgodę obejmującą obowiązkową świadomą zgodę na badanie genetyczne i zobowiązanie do przestrzegania wymagań oraz ograniczeń ujętych w treści formularzy świadomej zgody (ICF – z ang. Informed Consent Form) oraz protokołu badania
2. Wiek ≥18 lat w okresie przesiewowym
3. Osoby z rozpoznaniem histologicznie potwierdzonego NDRP (klasyfikacja WHO 2015) z kwalifikującą się do resekcji chorobą (stadium II-III)
4. Całkowita resekcja pierwotnego NDRP jest obowiązkowa

E.4

Principal exclusion criteria

1. Postoperative imaging demonstrating unequivocal evidence of disease recurrence or
tissue biopsy-proven disease recurrence
2. EGFR-mutant and/or ALK-translocation
3. Mixed small cell and NSCLC histology
4. Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab

1. Pooperacyjne badanie obrazowe jednoznacznie świadczące o wznowie choroby lub wznowa choroby potwierdzona wynikiem biopsji tkanki
2. Mutacja genu EGFR i/lub translokacja genu ALK
3. Cechy mieszane raka drobnokomórkowego i NDRP
4. Jakiekolwiek wcześniejsze leczenie adjuwantowe pod kątem NDRP lub wcześniejsza ekspozycja na durwalumab

E.5 End points

E.5.1

Primary end point(s)

DFS (using Investigator assessments according to RECIST 1.1) in FAS

Analiza DFS w populacji objętej analizą (FAS) (na podstawie oceny badacza wg RECIST 1.1)

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 4 years

około 4 lat

E.5.2

Secondary end point(s)

1. DFS (using Investigator assessments according to RECIST 1.1) in MRD+ analysis set.
2. OS in MRD+ analysis set and in FAS

1. Analiza DFS u pacjentów MRD+ (na podstawie oceny badacza wg RECIST 1.1)
2. Analiza OS u pacjentów MRD+ i w FAS

E.5.2.1

Timepoint(s) of evaluation of this end point

Approximately 4 years

około 4 lat

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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)

E.8.2.2

Placebo

Yes

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

Argentina

Australia

Brazil

Canada

Hong Kong

India

Israel

Japan

Korea, Republic of

Mexico

Peru

Singapore

Taiwan

Thailand

United States

Viet Nam

France

Poland

Sweden

Bulgaria

Netherlands

Romania

Spain

Switzerland

Czechia

Germany

Greece

Italy

Belgium

Denmark

Hungary

Russian Federation

Turkey

United Kingdom

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

The end of study is defined as the last expected visit/contact of the last patient undergoing the
study.

Zakończenie badania zdefiniowano jako ostatnią zakładaną wizytę/kontakt ostatniego pacjenta uczestniczącego w badaniu.

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

E.8.9.2

In all countries concerned by the trial days

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.4.2.2

In the whole clinical trial

100

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)

None

Nie dotyczy

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-09-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-08-31

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