Clinical Trials Register

Summary
EudraCT Number:	2020-001050-22
Sponsor's Protocol Code Number:	DOLPHIN
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-09-07
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

Germany - PEI

A.2

EudraCT number

2020-001050-22

A.3

Full title of the trial

A Phase II randomized Study to evaluate the efficacy and safety of Cisplatin or Carboplatin
/ Etoposide and concomitant Radiotherapy combined with Durvalumab followed by
Maintenance Therapy with Durvalumab versus Cisplatin or Carboplatin / Etoposide and
concomitant Radiotherapy in Patients with limited disease Small Cell Lung Cancer

Eine randomisierte Phase II-Studie zur Bewertung der Wirksamkeit und Sicherheit von Cisplatin oder Carboplatin / Etoposid und begleitender Strahlentherapie in Kombination mit Durvalumab, gefolgt von einer Erhaltungstherapie mit Durvalumab verglichen mit Cisplatin oder Carboplatin / Etoposid und begleitender Strahlentherapie bei Patienten mit lokal begrenzter Erkrankung des kleinzelligen Lungenkrebses

A.3.1

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

A study on the efficacy and safety of cisplatin/etoposide and concomitant radiotherapy in combination with durvalumab, an immunotherapy, in patients with local limited small cell lung cancer.

Eine Studie um die Wirksamkeit und Sicherheit von Cisplatin / Etoposid und begleitender Strahlentherapie in Kombination mit Durvalumab, einer Immuntherapie, bei Patienten mit lokal begrenzten kleinzelligen Lungenkrebs.

A.4.1

Sponsor's protocol code number

DOLPHIN

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04602533

A.5.4

Other Identifiers

Name:

For.UM Mainz

Number:

19-00778

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	Universitätsmedizin Mainz, Interdisziplinäres Zentrum klinische Studien
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinikum Gießen Marburg
B.5.2	Functional name of contact point	Prof. Dr. med. Thomas Wehler
B.5.3	Address:
B.5.3.1	Street Address	Rudolf Buchheim-Str 8
B.5.3.2	Town/ city	Gießen
B.5.3.3	Post code	35392
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4915142510000
B.5.5	Fax number	+496429854 1789
B.5.6	E-mail	Thomas.wehler@innere.med.uni-giessen.de

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	Yes
D.2.1.1.1	Trade name	IMFINZI® 50 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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 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.3.9.3	Other descriptive name	MEDI4736
D.3.9.4	EV Substance Code	SUB176342
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)	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Limited Disease Small Cell Lung Cancer

Lokal begrenzte Erkrankung des kleinzelligen Lungenkrebses

E.1.1.1

Medical condition in easily understood language

Small Cell Lung Cancer

Kleinzelliger Lungenkrebs

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	10041069
E.1.2	Term	Small cell lung cancer limited stage
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

Superior efficacy in the Durvalumab treatment group versus control group measured by progression-free survival (PFS) after 18 months.

Überlegene Wirksamkeit der Durvalumab-Behandlungsgruppe verglichen mit der Kontrollgruppe gemessen anhand des progressionsfreien Überlebens (PFS) nach 18 Monaten.

E.2.2

Secondary objectives of the trial

Superior efficacy in the Durvalumab treatment group versus control group by means of overall survival (OS), Quality of life (QoL), overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS) at any other tumor assessments, Safety and Tolerability.

Überlegene Wirksamkeit der Durvalumab-Behandlungsgruppe verglichen mit der Kontrollgruppe mit Hilfe von Gesamtüberleben (OS), Lebensqualität (LQ), Gesamtansprechrate (ORR), Krankheitskontrollrate (DCR), progressionsfreies Überleben (PFS) bei allen anderen Tumor-Beurteilungen, Sicherheit und Verträglichkeit.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects meeting all of the following criteria will be considered for enrollment to the trial:
1. Signed and dated informed consent of the subject must be available before start of any
specific trial procedures
2. Male or female ≥ 18 years
3. Histological confirmed limited disease small cell lung cancer (stage 2 and 3; T2-4, N1-3,
M0 according UICC8 criteria), if primarius is not eligible as RECIST1.1 target lesion (in
cases with T1a and T1b) at least one lymph node must meet RECIST1.1 criteria for target
lesion (≥15 mm short axis)
4. Availability of tumor tissue or fresh tumor material for translational research by central lab
testing
5. ECOG PS 0 – 1
6. At least one measurable lesion according RECIST 1.1
7. Body weight > 30 kg
8. Adequate normal organ function
a. Hemoglobin ≥ 9.0 g/dL
b. Absolute neutrophil count (ANC) ≥ 1.5 x109/L
c. Platelet count ≥ 100 x109/L
d. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal
e. Serum Bilirubin ≤ 1.5 x institutional upper limit of normal
f. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min for Carboplatin, ≥60
mL/min for Cisplatin, calculated by the Cockcroft-Gault formula
9. Life expectancy of at least 12 weeks in the discretion of the investigator
10. Ability of subject to understand nature, importance and individual consequences of clinical
trial

1. Die unterzeichnete und datierte Einwilligungserklärung des Patienten muss vor Beginn von studienspezifischen Maßnahmen vorliegen
2. Männlich oder weiblich ≥ 18 Jahre
3. Histologisch bestätigte lokal begrenzte Erkrankung (limited disease) des SCLC (Stadium 2 und 3; T2-T4, N1-3, M0 gemäß UICC8-Kriterien), wenn der Primarius nicht als RECIST1.1-Zielläsion in Frage kommt (bei Fällen mit T1a und T1b) muss mindestens ein Lymphknoten die RECIST1.1-Kriterien für eine Zielläsion erfüllen (≥15 mm kurze Achse)
4. Verfügbarkeit von Tumorgewebe oder frischem Tumormaterial für die translationale Forschung durch ein Zentrallabor
5. ECOG PS 0 – 1
6. Mindestens eine messbare Läsion nach RECIST1.1
7. Körpergewicht > 30 kg
8. Adäquate normale Organfunktion:
a. Hämoglobin ≥ 9.0 mg/dL
b. Absolute Neutrophilenzahl (ANC) ≥ 1.5 x109/L
c. Thrombozytenzahl ≥ 100 x109/L
d. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutioneller oberer Normgrenze
e. Serum Bilirubin ≤ 1.5 x institutioneller oberer Normgrenze
f. Geschätzte glomeruläre Filtrationsrate (eGFR) ≥ 30 mL/min für Carboplatin, ≥ 60 mL/min für Cisplatin, berechnet nach der Cockcroft-Gault Formel
9. Lebenserwartung von mindestens 12 Wochen im Ermessen des Prüfarztes
10. Fähigkeit des Patienten, Wesen, Bedeutung und individuelle Konsequenzen der klinischen Prüfung zu verstehen

E.4

Principal exclusion criteria

1. Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV)
2. Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy
3. History of allogenic organ transplantation
4. Active or prior documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g. colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome or Wegener syndrome [granulomatosis with polyangiitis], Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion:
a. Patients with vitiligo or alopecia
b. Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
c. Patients with any chronic skin condition that not required systemic therapy
d. Patients without active disease in the last 5 years may be included but only after consultation with the study physician
e. Patients with celiac disease controlled by diet alone
5. Uncontrolled intercurrent illness (i.e. active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious chronic gastrointestinal conditions (i.e. diarrhea), psychiatric illness)
6. History of another primary malignancy in the last 5 years, except adequately treated non-melanoma skin cancer, adequately treated carcinoma in situ (without evidence of disease)
7. History of leptomeningeal carcinomatosis, or brain metastases
8. Known HIV positive and/or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
9. Current or prior use of immunosuppressive medication within 14 days before the first dose. The following are exceptions to this criterion:
a. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
b. Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent
c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
10. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP
11. Participation in another clinical trial with an investigational product within the last 30 days (unless during follow-up period of an interventional study)
12. Known hypersensitivity to one of the ingredients
13. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial
14. Pregnancy, lactation and contraception
a. Women who are pregnant, nursing or who plan to become pregnant while in the trial
b. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and for the drug out washout period (90 days after last dose of Durvalumab and/or 6 months after last dose of
cisplatin and etoposide)).
15. Patients who are legally institutionalized

1. Metastasierte Erkrankung (extensive disease) des SCLC (Tx, Nx, M1, stage 4)
2. Größerer chirurgischer Eingriff innerhalb von 28 Tagen vor der ersten Dosis des Studienmedikamentes und/oder Radiochemotherapie
3. Vorgeschichte einer allogenen Organtransplantation
4. Aktive oder früher dokumentierte Autoimmun- oder entzündliche Erkrankung (einschließlich entzündlicher Darmerkrankungen [z.B. Colitis oder Morbus Crohn], Divertikulitis [mit Ausnahme der Divertikulose], systemischer Lupus erythematodes, Sarkoidose-Syndrom oder Wegener-Syndrom [Granulomatose mit Polyangiitis], Morbus Basedow, rheumatoide Arthritis, Hypophysitis, Uveitis usw.]. Ausnahmen von diesem Kriterium sind die Folgenden:
a. Patienten mit Vitiligo oder Alopezie
b. Patienten mit Schulddrüsenunterfunktion (z.B. nach Hashimoto-Syndrom), die mit Hormonersatz stabil sind
c. Jede chronische Hauterkrankung, die keine systemische Therapie erfordert
d. Patienten ohne aktive Erkrankung in den letzten 5 Jahren können einbezogen werden, aber nur nach Rücksprache mit dem Studienarzt
e. Patienten mit Zöliakie, die allein durch die Ernährung kontrolliert sind
5. Unkontrollierte interkurrente Erkrankung (d.h. aktive Infektion, symptomatische Herzinsuffizienz, unkontrollierter Bluthochdruck, instabile Angina pectoris, interstitielle Lungenerkrankung, schwere chronische gastrointestinale Erkrankungen (z.B. Durchfall), psychiatrische Erkrankungen)
6. Vorgeschichte eines weiteren primären Malignoms in den letzten 5 Jahren, mit Ausnahme von adäquat behandeltem Nicht-Melanom-Hautkrebs, adäquat behandeltem Carcinoma in situ (ohne Krankheitsnachweis)
7. Vorgeschichte einer leptomeningealen Karzinomatose oder von Hirnmetastasen
8. Bekannte HIV Infektion und/oder aktive Infektion einschließlich Tuberkulose (klinische Bewertung, welche die klinische Vorgeschichte, physische Untersuchung und radiologische Befunde sowie Tuberkulosetests entsprechend der lokalen Praxis umfaßt), Hepatitis B (bekanntermaßen positives Ergebnis des HBV-Oberflächenantigens (HBsAg), Hepatitis C. Patienten mit einer früheren oder ausgeheilten HBV-Infektion (Vorhandensein von Hepatits-B-Kernantikörpern [anti-Hbc] und das Fehlen von HBsAg) können eingeschlossen werden. Patienten, die positiv auf Hepatitis C (HCV)-Antikörper reagieren, kommen nur dann in Frage, wenn die Polymerase-Kettenreaktion negativ für HCV-RNA ist.
9. Gegenwärtige oder frühere Einnahme von immunsuppressiven Medikamenten innerhalb von 14 Tagen vor der ersten Dosis. Die folgenden sind Ausnahmen von diesem Kriterium:
a. Intranasale, inhalative, topische Steroide oder lokale Steroid-Injektionen (z.B. intra-artikuläre Injektion)
b. Systemische Kortikosteroide in physiologischen Dosen von nicht mehr als 10 mg/day Prednison oder dessen Äquivalent
c. Steroide als Premedikation für Überempfindlichkeitsreaktionen (z.B. CT-Scan Premedi¬kation)
10. Erhalt eines attenuierten Lebendimpfstoffes innerhalb von 30 Tagen vor der ersten Dosis des IMP
11. Teilnahme an einer anderen klinischen Studie mit einem Prüfpräparat innerhalb der letzten 30 Tage (außer während der Nachbeobachtungsphase einer interventionellen Studie)
12. Bekannte Überempfindlichkeit gegen einen der Inhaltsstoffe
13. Medizinische oder psychologische Bedingungen, die einen angemessenen und ordnungs¬gemäßen Abschluss der Studie gefährden würden
14. Schwangerschaft, Stillzeit und Verhütung
a. Frauen, die während der Studie schwanger sind, stillen oder planen, schwanger zu werden
b. Frauen mit gebärfähigem Potential (WOCBP) und Männer, die in der Lage sind, ein Kind zu zeugen, die nicht bereit sind, abstinent zu sein oder hochwirksame Methoden der Empfängnisverhütung anzuwenden, die bei konsequenter und korrekter Anwendung, zu einer niedrigen Fehlerrate von weniger als 1% pro Jahr führen, beginnend mit der Einwilligungserklärung, während der Dauer der medikamentösen Behandlung und während der Auswaschphase (90 Tage nach der letzten Dosis Durvalumab und/oder 6 Monate nach der letzten Dosis von Cisplatin uund Etoposid). Für weitere Details siehe Anhang 1.
15. Patienten, welche gesetzlich in einer Anstalt verwahrt sind

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only.

Progressionsfreies Überleben (PFS) nach 18 Monaten gemäß RECIST1.1 sowie iRECIST für die Durvalumab-Gruppe.

E.5.1.1

Timepoint(s) of evaluation of this end point

18 months after first dose

18 Monate nach erster Gabe der Studientherapie

E.5.2

Secondary end point(s)

Progression-free survival (PSF) after other assessments
Overall survival (OS)
Overall response rate (ORR)
Disease control rate (DCR)
Safety and Tolerability
Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30, QLQ-LC13 and EQ-5D

Progressionsfreies Überleben (PSF) bei allen anderen Tumor-Beurteilungen
Gesamtüberleben (OS)
Gesamtansprechrate (ORR)
Krankheitskontrollrate (DCR)
Sicherheit und Verträglichkeit
Symptomkontrolle bewertet anhand der vom Patienten berichteten Lebensqualität (QoL) mittels QLQ-C30, QLQ-LC13 und EQ-5D

E.5.2.1

Timepoint(s) of evaluation of this end point

at different timepoints

zu unterschiedlichen Zeitpunkten

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

Letzter Besuch letzter Patient

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

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

105

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)

No study treatment is planned after induction phase in the control group as well as after induction
and/or maintenance phase in Durvalumab group until disease progression. In case of disease
progression, patients are treated according to standard of care 2nd line regimens (i.e. Topotecan).

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

2020-09-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-08-31

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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