Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Phase 2 Active not recruiting 528 enrolled AstraZeneca

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-12-18
Primary completion: 2024-09-13
Completion: 2026-09-11

Publications

Besse B, Pons-Tostivint E, Park K, Hartl S, Forde PM, Hochmair MJ, Awad MM, Thomas M, Goss G, Wheatley-Price P, Shepherd FA, Florescu M, Cheema P, Chu QSC, Kim SW, Morgensztern D, Johnson ML, Cousin S, Kim DW, Moskovitz MT, Vicente D, Aronson B, Hobson R, Ambrose HJ, Khosla S, Reddy A, Russell DL, Keddar MR, Conway JP, Barrett JC, Dean E, Kumar R, Dressman M, Jewsbury PJ, Iyer S, Barry ST, Cosaert J, Heymach JV. Biomarker-directed targeted therapy plus durvalumab in advanced non-small-cell lung cancer: a phase 2 umbrella trial. Nat Med. 2024 Mar;30(3):716-729. doi: 10.1038/s41591-024-02808-y. Epub 2024 Feb 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cediranib	Small molecule	20 mg	Oral
Subject	Ceralasertib	Small molecule	160 mg	Oral
Subject	Ceralasertib	Small molecule	240 mg	Oral
Subject	Danvatirsen	Antisense oligonucleotide	200 mg	Intravenous
Subject	Durvalumab	Monoclonal antibody	1120 mg	Intravenous
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Olaparib	Small molecule	300 mg	Oral
Subject	Oleclumab	Monoclonal antibody	3000 mg	Intravenous
Subject	Trastuzumab deruxtecan	Monoclonal antibody	5.4 mg/kg	Intravenous
Subject	Vistusertib	Small molecule	125 mg	Oral

Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Summary

Timeline

Publications

Drugs

Indications