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Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION) (DURATION)

  • identifier


  • Recruitment Status

    Active, not recruiting

  • First Posted

    November 17, 2017

  • Last update posted

    May 18, 2022

Study Description

Brief summary:

AIO-YMO/TRK-0416 (DURATION) is a open-label, treatment stratified and randomized phase II study of Durvalumab, frail or elderly patients with metastatic non-squamous NSCLC with no targetable molecular alterations (EGFRwt; ALKtransl-) and not amenable to cisplatinum-based standard-combination chemotherapy but eligible for at-least mono-chemotherapy with gemcitabine or vinorelbine.

  • Condition or Disease:
  • Intervention/Treatment:
  • Phase: Phase 2

Detailed Description

The primary objective is to assess the safety and tolerability of sequential therapy consisting of standard of care mono- or combination chemotherapy followed by durvalumab in comparison to standard of care mono- or combination chemotherapy in frail/elderly patients.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION)
  • Actual Study Start Date: December 2017
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: December 2022

Outcome Measures

Eligibility Criteria

  • Ages Eligible for Study:
  • Sexes Eligible for Study:
  • Accepts Healthy Volunteers:


Contacts and Locations



Sponsors and Collaborators

More Information

  • Responsible Party:
  • Identifier: NCT03345810 History of Changes
  • Other Study ID Numbers:
  • First Posted: November 17, 2017 Key Record Dates
  • Last Update Posted: May 18, 2022
  • Last Verified: May 2022
  • Individual Participant
    Data (IPD) Sharing

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No