For Healthcare Professionals

Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

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About the study

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

:

  1. Subjects with histologically
  2. or cytologically-documented NSCLC
  3. Locally advanced, unresectable (Stage III) NSCLC
  4. World Health Organisation (WHO) performance status 0-1
  5. At least one measurable lesion, not previously irradiated
  6. Must have a life expectancy of at least 12 weeks at randomization Principal

EXCLUSION CRITERIA

:

  1. Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
  2. Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.
  3. History of allogeneic organ transplantation
  4. Active or prior documented autoimmune or inflammatory disorders
  5. Uncontrolled intercurrent illness
  6. History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency
  7. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
  8. Mixed small cell and NSCLC histology
  9. Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling
  10. Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
  11. Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Non-Small Cell Lung Cancer

Age

18+

Phase

Phase 3

Participants needed

328

Est. Completion Date

Oct 2024

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT03519971

Study number

D933KC00001

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