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Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study

NCT04392505 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-29

No results posted yet for this study

Summary

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.

The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

Conditions

  • Cancer
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Stage III
  • NSCLC
  • NSCLC, Stage III

Interventions

DRUG

Durvalumab Injection

Included patients will receive durvalumab (fixed dose, 1500mg Q4W) until progressive disease and no clinical benefit, intolerable toxicity or patient's wish, for a maximum duration of 12 months. Treatment with durvalumab should start \<5 weeks after last radiotherapy dosing.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Åslaug Helland, Prof, MD · Oslo University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2025-05-01
Completion
2033-05-01

Countries

  • Estonia
  • Finland
  • Lithuania
  • Norway

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392505 on ClinicalTrials.gov