Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

Phase 2 Completed 15 enrolled Seoul National University Hospital AstraZeneca · collab Korean Cancer Study Group · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.

Timeline

Start: 2018-01-04
Primary completion: 2021-08-03
Completion: 2021-08-03

Outcome

Missed primary endpoint

paper which did not meet the stage 1 threshold (objective response ≥ 2/15). PMID 38986212 ↗

Publications

Kim YJ, Kim S, Kim TM, Suh KJ, Kim M, Kim SH, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of osimertinib in patients with NSCLC harboring EGFR exon 20 insertion: A multicenter trial of the Korean Cancer Study Group (LU17-19). Lung Cancer. 2024 Aug;194:107870. doi: 10.1016/j.lungcan.2024.107870. Epub 2024 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Osimertinib	Small molecule	80 mg	Oral

Indications

No indication recorded.