Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study

Phase 1/2 Active not recruiting 43 enrolled MedImmune LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced EGFRm NSCLC.

Timeline

Start: 2018-05-08
Primary completion: 2021-05-24
Completion: 2026-11-06

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Primary end points included safety and objective response rate by Response Evaluation Criteria in Solid Tumors version 1.1. PMID 36641093 ↗

paper objective response rate was 25.0% at DL1 and 11.8% at DL2 (all partial responses); PMID 36641093 ↗

Publications

Kim DW, Kim SW, Camidge DR, Shu CA, Marrone KA, Le X, Blakely CM, Park K, Chang GC, Patel SP, Kar G, Cooper ZA, Samadani R, Pluta M, Kumar R, Ramalingam S. CD73 Inhibitor Oleclumab Plus Osimertinib in Previously Treated Patients With Advanced T790M-Negative EGFR-Mutated NSCLC: A Brief Report. J Thorac Oncol. 2023 May;18(5):650-656. doi: 10.1016/j.jtho.2022.12.021. Epub 2023 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oleclumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Oleclumab	Monoclonal antibody	3000 mg	Intravenous
Subject	Osimertinib	Small molecule	80 mg	Oral
Subject	imaradenant	Small molecule	—	Oral