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NCT04078152CompletedPhase 4

Durvalumab Long-Term Safety and Efficacy Study

An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

Source: ClinicalTrials.gov · Last updated 20 Dec 2024

Brief summary (registry, in English)

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
163 (actual)
First submitted
9 Aug 2019
Start date
5 Sept 2019
Primary completion date
31 Oct 2022
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT04078152
EudraCT number
2019-001402-20

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 163
  • From 5 Sept 2019 to the primary completion date, 31 Oct 2022
  • 104 sites in 31 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The following exclusion criteria apply only to patients receiving treatment or retreatment:
  • Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab
  • Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment

Other illness

  • Diagnosis of a new primary malignancy since enrollment into the parent clinical study

Other

  • Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study

Who the study is looking for

  • Patient must be 18 years or older, at the time of signing the ICF. For subjects aged \< 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
  • Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
  • Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).
  • Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (104)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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RosarioArgentinaUnknown status
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Box HillAustraliaUnknown status
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MelbourneAustraliaUnknown status
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BrusselsBelgiumUnknown status
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KortrijkBelgiumUnknown status
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LeuvenBelgiumUnknown status
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SofiaBulgariaUnknown status
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FlorianópolisBrazilUnknown status
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IjuíBrazilUnknown status
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Porto AlegreBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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CalgaryCanadaUnknown status
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Greater SudburyCanadaUnknown status
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NewmarketCanadaUnknown status
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TorontoCanadaUnknown status
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BellinzonaSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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SantiagoChileUnknown status
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OlomoucCzechiaUnknown status
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DresdenGermanyUnknown status
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HanoverGermanyUnknown status
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BadalonaSpainUnknown status
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BarcelonaSpainUnknown status
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GironaSpainUnknown status
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JaénSpainUnknown status
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MadridSpainUnknown status
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MálagaSpainUnknown status
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MarbellaSpainUnknown status
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ValenciaSpainUnknown status
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BrestFranceUnknown status
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LilleFranceUnknown status
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LyonFranceUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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Holargos, AthensGreeceUnknown status
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BudapestHungaryUnknown status
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MiskolcHungaryUnknown status
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HaifaIsraelUnknown status
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ChennaiIndiaUnknown status
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Bunkyō CityJapanUnknown status
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FukushimaJapanUnknown status
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Isehara-shiJapanUnknown status
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Izumi-shiJapanUnknown status
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Kishiwada-shiJapanUnknown status
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KōtokuJapanUnknown status
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Nagaoka-shiJapanUnknown status
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NagoyaJapanUnknown status
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Natori-shiJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SagaJapanUnknown status
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Suita-shiJapanUnknown status
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Sunto-gunJapanUnknown status
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TokushimaJapanUnknown status
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YokohamaJapanUnknown status
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DaeguSouth KoreaUnknown status
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GwangjuSouth KoreaUnknown status
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Gyeongsangnam-doSouth KoreaUnknown status
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SeoguSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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KuchingMalaysiaUnknown status
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AmsterdamNetherlandsUnknown status
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ArnhemNetherlandsUnknown status
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LodzPolandUnknown status
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OlsztynPolandUnknown status
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CraiovaRomaniaUnknown status
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SuceavaRomaniaUnknown status
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KamenitzSerbiaUnknown status
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ArkhangelskRussiaUnknown status
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MoscowRussiaUnknown status
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OmskRussiaUnknown status
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pos.PesochnyiRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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BangkokThailandUnknown status
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SongkhlaThailandUnknown status
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New Taipei CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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ChernivtsіUkraineUnknown status
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Ivano-FrankivskUkraineUnknown status
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KharkivUkraineUnknown status
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KirovohradUkraineUnknown status
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Kryvyi RihUkraineUnknown status
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KyivUkraineUnknown status
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SumyUkraineUnknown status
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UzhhorodUkraineUnknown status
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VinnytsiaUkraineUnknown status
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AugustaUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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Chapel HillUnited StatesUnknown status
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DallasUnited StatesUnknown status
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FullertonUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HuntersvilleUnited StatesUnknown status
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MineolaUnited StatesUnknown status
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MinneapolisUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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Washington D.C.United StatesUnknown status
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HanoiVietnamUnknown status
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AdanaTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.