Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy
NCT03334617 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 528
Last updated 2025-10-27
Summary
This is an open-label, multi-centre, umbrella Phase II study in participants with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Conditions
Interventions
- DRUG
-
Participants will receive IV infusion of durvalumab as stated in arm description.
- DRUG
-
Danvatirsen
Participants will receive IV infusion of danvatirsen as stated in arm description.
- DRUG
-
Ceralasertib
Participants will receive oral tablet of ceralasertib as stated in arm description.
- DRUG
-
Vistusertib
Participants will receive oral tablets of vistusertib as stated in arm description.
- DRUG
-
Participants will receive oral tablets of olaparib as stated in arm description.
- DRUG
-
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arm description.
- DRUG
-
Participants will receive IV infusion of trastuzumab deruxtecan as stated in arm description.
- DRUG
-
Cediranib
Participants will receive oral tablets of cediranib as stated in arm description.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
John Heymach, M.D, Ph.D · The University of Texas MD Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-18
- Primary Completion
- 2024-09-13
- Completion
- 2026-09-11
- FDA Drug
- Yes
Countries
- United States
- Austria
- Canada
- France
- Germany
- Israel
- South Korea
- Spain
Study Locations
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