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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03345810

  • 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:

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

More Information

  • Responsible Party:
  • ClinicalTrials.gov 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
    Statement:

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