Clinical Trials Register

Summary
EudraCT Number:	2018-001375-21
Sponsor's Protocol Code Number:	D419AC00002
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:	2018-08-07
Trial 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

2018-001375-21

A.3

Full title of the trial

A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non Small-Cell Lung Cancer (NSCLC)

Globalne, wieloośrodkowe badanie III fazy, prowadzone z zastosowaniem metodyki próby otwartej i randomizacji, oceniające stosowanie durwalumabu w porównaniu ze standardową chemioterapią opartą na związkach platyny, podawanych w pierwszej linii u pacjentów z rozpoznaniem zaawansowanego niedrobnokomórkowego raka płuca (NDRP) o wysokiej ekspresji PD-L1 (ligandu receptora programowanej śmierci)

A.3.1

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

A study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer

Badanie oceniające (zastosowanie) durwalumab w porównaniu ze standardową chemioterapią u pacjentów z zaawansowanym niedrobnokomórkowym rakiem płuca

A.3.2

Name or abbreviated title of the trial where available

Pearl

A.4.1

Sponsor's protocol code number

D419AC00002

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03003962

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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	N/A
B.5.3.3	Post code	N/A
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+18772409479
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.3.9.3	Other descriptive name	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.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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Paclitaxel
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	Paclitaxel
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.IMP: 3
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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Carboplatin
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	Carboplatin
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.IMP: 4
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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Gemcitabine
D.3.4	Pharmaceutical form	Powder 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	Gemcitabine
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.IMP: 5
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.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Cisplatin
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	Cisplatin
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.IMP: 6
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.2.1.2	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.3.1	Product name	Pemetrexed
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	Pemetrexed
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

First line patients with Advanced Non Small-Cell Lung Cancer (NSCLC) with PD-L1 high membrane expression in tumoral tissue and lacking activating epdermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) infusions.

Wcześniej nieleczeni pacjenci z zaawansowanym niedrobnokomórkowym rakiem płuca (NDRP) bez mutacji w genach receptora naskórkowego czynnika wzrostu (EGFR) i kinazy chłoniaka anaplastycznego (ALK), z wysoką ekspresją PD L1.

E.1.1.1

Medical condition in easily understood language

Treatment naïve patients with specific type of lung cancer called 'non-small cell lung cancer'

Chorzy z typem raka płuca nazywanym „niedrobnokomórkowym rakiem płuca” (NDRP)

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10025055
E.1.2	Term	Lung cancer non-small cell stage IV
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

To assess the efficacy of durvalumab compared to Standard of care
(SoC) chemotherapy in all randomized patients and in patients who are
at low risk of early mortality (EM)

Ocena skuteczności durwalumabu w porównaniu z terapią standardową (SoC) u wszystkich zrandomizowanych pacjentów oraz w grupie pacjentów z niskim ryzykiem wczesnej śmiertelności (early mortality (EM))

E.2.2

Secondary objectives of the trial

To assess the efficacy of durvalumab compared to SoC in terms of Overall survival (OS) in PD-L1 high patients and in PD-L1 high with low risk of EM population
To assess the efficacy of durvalumab compared to SoC in terms of progression free survival (PFS), objective response rate (ORR), duration
of response (DoR), proportion of patients alive at 18 months from
randomization (OS18), proportion of patients alive at 24 months from randomization (OS24), proportion of patients alive and progression free at 12 months from randomization (APF12), and time from randomization to second progression (PFS2)
To assess disease-related symptoms and Health-related quality of life (HRQoL) in patients treated with durvalumab compared to SoC using the European Organisation for Research and Treatment of Cancer (EORTC)30-item core quality of life questionnaire, version 3 (QLQ-C30 v3) and the 13-item lung cancer quality of life questionnaire (LC13) module
To investigate the immunogenicity of durvalumab

1.Ocena skuteczności durwalumabu w porównaniu ze SoC pod względem OS u pacjentów z wysokim PD L1 oraz wysokim PD L1 i niskim ryzykiem EM;
2. Ocena skuteczności MEDI4736 w porównaniu ze SoC pod względem: czasu przeżycia bez progresji choroby (PFS), odsetka odpowiedzi obiektywnych (ORR), czasu trwania odpowiedzi (DoR), odsetka pacjentów żyjących 18 miesięcy po randomizacji (OS18), odsetka pacjentów żyjących 24 miesiące po randomizacji (OS24), odsetka pacjentów żyjących bez progresji choroby 12 miesięcy po randomizacji (APF12) i czasu od randomizacji do drugiej progresji choroby (PFS2);
3. Ocena związanych z chorobą objawów i jakości życia uwarunkowanej stanem zdrowia (HRQoL) u pacjentów otrzymujących leczenie MEDI4736 w porównaniu ze SoC, przy użyciu kwestionariusza EORTC - 30-punktowego standardowego kwestionariusza jakości życia, wersja 3 (QLQ C30 wer. 3) oraz modułu 13-punktowwgo kwestionariusza jakości życia u pacjentów z rakiem płuca (LC13);
4. Ocena immunogenności MEDI4736

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No sensitizing EGFR mutation or ALK rearrangement
- Prior to randomization, patients have PD-L1 high membrane expression in tumoral tissue with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory
- No prior chemotherapy or any other systemic therapy for advanced or metastatic NSCLC
- World Health Organization (WHO) Performance Status of 0 or 1

1. Wiek ≥18 lat podczas oceny przesiewowej;
2. Udokumentowany NDRP w stadium IV;
3. Nowotwory u pacjentów nie mogą wykazywać obecności uwrażliwiającej mutacji genu EGFR ani rearanżacji genu ALK;
4. Przed randomizacją u pacjenta musi występować status wysokiej ekspresji PD L1 zdefiniowany jako ekspresja błonowa PD L1 w tkance nowotworu w teście immunohistochemicznym Ventana SP263 PD L1 przeprowadzonym w laboratorium referencyjnym;
5. Pacjenci wcześniej nieleczeni z zastosowaniem chemioterapii lub jakakolwiek innej terapii ogólnoustrojowej w zaawansowanym NDRP.
6. Stan sprawności wg skali Światowej Organizacji Zdrowia (WHO) 0 lub 1 .

E.4

Principal exclusion criteria

• Prior chemotherapy or any other systemic therapy for advanced NSCLC
• Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
• Brain metastases or spinal cord compression unless the patient is stable (asymptomatic, no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment
• Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
• Active or prior documented inflammatory bowel disease
• Active infection
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

1. Wcześniejsza chemioterapia lub jakakolwiek inna terapia ogólnoustrojowa w zaawansowanym NDRP;
2. Mieszany rak płuca o histologii drobnokomórkowej i NDRP, wariant sarkomatoidalny.
3. Przerzuty do mózgu lub ucisk na rdzeń kręgowy, z wyjątkiem przypadków, w których stan pacjenta jest stabilny (nie występują objawy; nie występują oznaki nowych lub powstających przerzutów do mózgu) a kortykosteroidy nie są przyjmowane przez co najmniej 14 dni przed rozpoczęciem badanego leczenia;
4. Wcześniejsze leczenie immunologiczne, w tym w szczególności z zastosowaniem innych przeciwciał anty CTLA 4, anty PD 1, anty PD L1 i przeciwko ligandowi programowanej śmierci 2 (anty PD L2), z wyłączeniem leczniczych szczepionek przeciwnowotworowych;
5. Aktywna lub przebyta, udokumentowana zapalna choroba jelit;
6. Aktywne zakażenie;
7. Stosowanie leków immunosupresyjnych obecnie lub w okresie 14 dni poprzedzających przyjęcie pierwszej dawki durwalumabu.

E.5 End points

E.5.1

Primary end point(s)

przeżycie całkowite (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

This is anticipated to be 47 months from first patient randomized.

Zakładany termin to 47 miesiąc od daty randomizacji pierwszego pacjenta

E.5.2

Secondary end point(s)

Overall survival
Proportion of patients alive at 18 months from randomization (OS18)
Proportion of patients alive at 24 months from randomization (OS24)
Progression-free survival (PFS) using investigator assessments according to RECIST 1.1
Objective response rate (ORR) using investigator assessments according to RECIST 1.1
Duration of response (DoR) using investigator assessments according to RECIST 1.1
Proportion of patients alive and progression free at 12 months from randomization (APF12) using investigator assessments according to RECIST 1.1
Progression-free survival after subsequent anticancer therapy (PFS2)
Health-related QoL measured by EORTC QLQ-C30 v3
Disease-related symptoms measured by EORTC QLQ-LC13
Changes in WHO/ECOG performance status
The immunogenicity of durvalumab as assessed by presence of anti-drug antibodies (ADAs)

1. Przeżycie całkowite (OS);
2. Odsetek pacjentów żyjących 18 miesięcy po randomizacji (OS18);
3. Odsetek pacjentów żyjących 24 miesiące po randomizacji (OS24);
4. Czas przeżycia bez progresji choroby (PFS) na podstawie oceny badacza według kryteriów RECIST 1.1;
5. Odsetek odpowiedzi obiektywnych (ORR) na podstawie oceny badacza według kryteriów RECIST 1.1;
6. Czas trwania odpowiedzi (DoR) na podstawie oceny badacza według kryteriów RECIST 1.1;
7. Oodsetek pacjentów żyjących bez progresji choroby 12 miesięcy po randomizacji (APF12) na podstawie oceny badacza według kryteriów RECIST 1.1;
8. Czas od randomizacji do drugiej progresji choroby (PFS2);
9. Ocena jakości życia uwarunkowanej stanem zdrowia (HRQoL) na podstawie EORTC QLQ C30 w 30;
10.Ocena objawów związanych z chorobą u pacjentów z rakiem płuca na podstawie ERTC QLQ -LC13;
11.Zmiany stanu sprawności wg Wschodniej Grupy Współpracy Onkologicznej (ECOG)Światowej Organizacji Zdrowia (WHO);
12.Immunogeniczność durwalumabu ocenia ba podstawie obecności obecność przeciwciał przeciwko durwalumabowi (ADA).

E.5.2.1

Timepoint(s) of evaluation of this end point

Until end of study

Do zakończenia badania

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

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

Yes

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

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)

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

Australia

China

Korea, Republic of

Taiwan

Thailand

United States

Viet Nam

Poland

Netherlands

Hungary

Russian Federation

Turkey

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 visit of the last subject

„LVLS” (Last Visit Last Subject)

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

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:

430

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

220

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

650

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-08-23

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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