CompletedPhase 4NCT04078152
Official study title

Durvalumab Long-Term Safety and Efficacy Study

Study summary

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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab

The study team can explain what participation involves.

Who it may be forSolid Tumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 20, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?116 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 4
Sponsor
AstraZeneca
Interventions being studied
Drug: Durvalumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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. 2. 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. 3. 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). 4. Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

Reasons someone may not be able to joinExclusion criteria

The following

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteFullerton, California
  • Research SiteWashington D.C., District of Columbia
  • Research SiteAugusta, Georgia
  • Research SiteBaltimore, Maryland
  • Research SiteMinneapolis, Minnesota
  • Research SiteSt Louis, Missouri
  • Research SiteMineola, New York
  • Research SiteChapel Hill, North Carolina
  • Research SiteHuntersville, North Carolina
  • Research SiteGreenville, South Carolina
  • Research SiteNashville, Tennessee
  • Research SiteDallas, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 20, 2024. Always confirm current availability with the study team.

View original record ↗