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    EudraCT Number:2018-002294-22
    Sponsor's Protocol Code Number:D933YC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-11
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002294-22
    A.3Full title of the trial
    A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab as Consolidation Therapy in Patients with Locally Advanced, Unresectable, Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed following Definitive, Platinum-Based, Chemoradiation Therapy (PACIFIC-5)
    Randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane za pomocą placebo, wieloośrodkowe badanie fazy III, oceniające durwalumab w terapii konsolidacyjnej u pacjentów z miejscowo zaawansowanym, nieoperacyjnym niedrobnokomórkowym rakiem płuca (w III stadium zaawansowania), u których nie wystąpiła progresja po definitywnej, opartej na pochodnych platyny, chemioradioterapii (PACIFIC 5)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Durvalumab as consolidation therapy in lung cancer (PACIFIC-5 Study)
    Badanie oceniające durwalumab w terapii konsolidacyjnej u pacjentów z rakiem płuca (Badanie PACIFIC-5)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD933YC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03706690
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdurvalumab
    D.3.9.1CAS number 1428935607
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced unresectable, non small cell lung cancer who have not progressed following definitive, platinum-based chemoradiation therapy
    Miejscowo zaawansowany, nieoperacyjny niedrobnokomórkowy rak płuca bez progresji po definitywnej, opartej na pochodnych platyny, chemioradioterapii
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "non small cell lung cancer"
    Określony typ raka płuca nazywany „niedrobnokomórkowym rakiem płuca”
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of durvalumab treatment compared with placebo in terms of PFS in randomised patients without sensitizing EGFR mutations or ALK rearrangements (i.e. mITT population).
    Ocena skuteczności leczenia durwalumabem w porównaniu z placebo pod względem wpływu na czas przeżycia bez progresji choroby (PFS) u pacjentów zrandomizowanych bez mutacji EGFR zwiększającej wrażliwość lub rearanżacji ALK (populacja mITT).
    E.2.2Secondary objectives of the trial
    To assess OS of durvalumab in comparison with placeboin in the mITT, and separately in ITT,
    To assess the efficacy of durvalumab treatment compared with placebo in terms of PFS in ITT,
    To assess the Objective Response Rate of durvalumab in comparison with placebo in the mITT, and separately in ITT
    To assess safety and tolerability profile of Durvalumab,;
    To assess PK and immunegeneity of Durvalluamb;
    To identify potential predictive biomarker for durvalumab; Factors potentially associated with durvalumab's response will be analyzed for providing the rationale for future patient selection;
    To investigate the relationship between a patient's tissue TMB and efficacy outcomes with durvalumab (China is not included)
    Ocena skuteczności durwalumabu w porównaniu z placebo pod względem całkowitego czasu przeżycia (OS) w zmodyfikowanej analizie populacji mITT oraz oddzielnie w analizie populacji ITT;
    Ocena skuteczności durwalumabu w porównaniu z placebo pod względem wpływu na czas przeżycia bez progresji choroby (PFS) w populacji ITT;
    Ocena skuteczności durwalumabu w porównaniu z placebo pod względem odsetka odpowiedzi obiektywnych (ORR) w populacji mITT oraz oddzielnie ITT
    Ocena profilu bezpieczeństwa i tolerancji durwalumabu;
    Ocena farmakokinetyki (PK) i immunogenności durwalumabu;
    Identyfikacja potencjalnego biomarkera predykcyjnego dla durwalumabu; czynniki potencjalnie związane z odpowiedzią na leczenie durwalumabem będą analizowane w celu możliwości prospektywnego identyfikowania pacjentów
    Ocena związku pomiędzy obciążeniem mutacjami w tkance nowotworowej (TMB) w tkankach pacjenta a punktami końcowymi oceniającymi skuteczność durwalumabu (z wykluczeniem Chin).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Age≥18 years
    2 Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
    3 Receipt of concurrent or sequential chemoradiation therapy,
    4 No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
    5 World Health Organization (WHO) PS of 0 or 1;
    6 No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
    7 Adequate organ and marrow function required
    8 Life expectancy of at least 12 weeks
    9.Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
    1.Wiek ≥18 lat;
    2.Udokumentowany histologicznie lub cytologicznie niedrobnokomórkowy rak płuca (NDRP), miejscowo zaawansowany, nieoperacyjny (w stadium III);
    3.Otrzymanie jednoczasowej (cCRT) lub sekwencyjnej (sCRT) chemioradioterapii;
    4.Nie może wystąpić progresja choroby po definitywnej, opartej na pochodnych platyny, jednoczasowej lub sekwencyjnej chemioradioterapii;
    5.Stan sprawności (PS) w skali Światowej Organizacji Zdrowia (WHO) musi wynosić 0 lub 1;
    6.Nie jest dozwolona wcześniejsza ekspozycja na jakiekolwiek przeciwciała anty CTLA 4, anty PD 1, anty PD L1 i anty PD L2, z wyłączeniem leczniczych szczepionek przeciwnowotworowych;
    7.Wydolna czynność narządów i szpiku kostnego
    8.Przewidywany czas przeżycia wynoszący co najmniej 12 tygodni;
    9.Przed randomizacją musi być znany status PD L1 nowotworu, określony w teście IHC Ventana SP263 PD L1 przez laboratorium referencyjne.
    E.4Principal exclusion criteria
    1 History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
    2. Active or prior documented autoimmune or inflammatory disorders
    3. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
    4. Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies).
    5. Mixed small cell and NSCLC histology, sarcomatoid variant
    6. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
    7. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
    8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
    1.Stan po allogenicznym przeszczepieniu narządu lub inny pierwotny nowotwór złośliwy w wywiadzie lub aktywny pierwotny niedobór immunologiczny;
    2.Udokumentowane aktywne lub wcześniej przebyte choroby autoimmunologiczne lub zapalne;
    3.Niekontrolowane choroby współistniejące, które mogłyby ograniczać możliwość przestrzegania przez pacjenta wymogów badania, istotnie zwiększać ryzyko wystąpienia zdarzeń niepożądanych lub upośledzać zdolność pacjenta do wyrażenia świadomej zgody na piśmie;
    4.Aktywne zakażenie, w tym gruźlica, wirusowe zapalenie wątroby typu B, wirusowe zapalenie wątroby typu C (HCV) lub zakażenie ludzkim wirusem upośledzenia odporności (dodatni wynik badania na obecność przeciwciał przeciw ludzkiemu wirusowi upośledzenia odporności [HIV] 1/2);
    5.Typ histologiczny: mieszany drobnokomórkowy i niedrobnokomórkowy rak płuca, wariant z elementami mięsakowymi;
    6.Jakiekolwiek utrzymujące się działania toksyczne stopnia ≥2 związane z wcześniejszą chemioradioterapią oceniane według wspólnych kryteriów terminologicznych dla zdarzeń niepożądanych (CTCAE) wg Narodowego Instytutu Onkologicznego (NCI);
    7.Otrzymanie żywej atenuowanej szczepionki w okresie 30 dni przed pierwszą dawką produktu badanego;
    8.Poważna operacja chirurgiczna (w ocenie badacza) w okresie 28 dni przed przyjęciem pierwszej dawki produktu badanego.
    E.5 End points
    E.5.1Primary end point(s)
    PFS using BICR assessments according to RECIST 1.1
    PFS na podstawie ocen BICR zgodnie z kryteriami RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    On-study tumour assessments occur every 8 weeks ±1 week for the first 48 weeks and then every 12 weeks ±1 week thereafter until disease progression.
    Ocena nowotworów w trakcie badania będzie miała miejsce co 8 tygodni ± 1 tydzień w przypadku pierwszych 48 tygodni, a następnie co 12 tygodni ± 1 tydzień, aż do wystąpienia progresji choroby.
    E.5.2Secondary end point(s)
    OS of durvalumab in comparison with placebo,
    Objective Response Rate of durvalumab in comparison with placebo,
    Safety and tolerability profile of Durvalumab,;
    PK and immunogenicity of Durvalumb;
    Potential predictive biomarker for durvalumab; Factors potentially associated with durvalumab' response will be analyzed for providing the rationale for future patient selection.
    OS durwalumabu w porównaniu z placebo;
    ORR durwalumabu w porównaniu z placebo;
    Profil bezpieczeństwa i tolerancji durwalumabu;
    PK i immunogenność durwalumabu;
    Potencjalne biomarkery predykcyjnego dla durwalumabu; czynniki potencjalnie związane z odpowiedzią na leczenie durwalumabem będą analizowane w celu możliwości prospektywnego identyfikowania pacjentów.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For OS - from baseline to until death due to any cause.
    For ORR - at baseline, then every 8 weeks for the first 48 weeks relative to the date of randomization, and then every 12 weeks until progression.
    For Safety and tolerability - from randomization until 3 months after treatment discontinuation
    For PK (durvalumab): on Day1, week 4, 12 from randomization; and 3 months after treatment discontinuation
    Dla OS – od danych wyjściowych do wystąpienia zgonu z dowolnej przyczyny
    Dla ORR – dane wyjściowe, następnie co 8 tygodni przez pierwszych 48 tygodni zgodnie z datą randomizacji, a następnie co 12 tygodni aż do wystąpienia progresji;
    Dla bezpieczeństwa i tolerancji – od randomizacji aż do 3 miesięcy po zakończeniu leczenia
    Dla PK (durwalumab): w pierwszym dniu, 4 i 12 tygodniu od daty randomizacji i do 3 miesięcy po przerwaniu leczenia.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    Russian Federation
    E.8.7Trial 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 Subject Last Visit (last expected visit/contact of the last patient undergoing the study)
    LVLS (Last Visit Last Subject) – przewidywane ostatnia wizyta/kontakt z ostatnim pacjentem uczestniczącym w badaniu)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 400
    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)
    After the final analysis, AstraZeneca will continue to supply open-label drug to patients receiving durvalumab monotherapy up to the time that they discontinue the treatment for whatever reason.
    Po przeprowadzeniu finalnej analizy, AstraZeneca będzie kontynuowała dostawy leku w formie badania otwartego pacjentom przyjmującym durwalumab w monoterapii do chwili przerwania przez nich leczenia z dowolnego powodu.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-06
    P. End of Trial
    P.End of Trial StatusOngoing
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