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

Phase 2 Completed 200 enrolled AIO-Studien-gGmbH AstraZeneca · collab Celgene Corporation · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-12-14
Primary completion: 2022-12-31
Completion: 2022-12-31

Publications

Kuon J, Hommertgen A, Krisam J, Lasitschka F, Stenzinger A, Blasi M, Bozorgmehr F, Maenz M, Kieser M, Schneider M, Thomas M. Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial. Trials. 2020 Apr 22;21(1):352. doi: 10.1186/s13063-020-04280-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	—
Subject	Durvalumab	Monoclonal antibody	1500 mg	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Nab-paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Vinorelbine	Small molecule	30 mg/m2	—

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

Summary

Timeline

Publications

Drugs

Indications