NCT03424759

Uncommon EGFR AZD9291

Status unknown Phase 2 Last updated 7 February 2018

What this trial tests

Phase 2 trial testing AZD9291 in Non Small Cell Lung Cancer in 37 participants. Status unknown.

Timeline

1 January 2016

Primary endpoint
31 December 2017

31 July 2019

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 January 2016
Primary completion	31 December 2017
Estimated completion	31 July 2019
Sites	1 location across South Korea

Drugs / interventions tested

• AZD9291 — full drug profile →

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Samsung Medical Center

Who can join

19 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

EGFR (ErbB1) mutations define a lung cancer subtype with exquisite sensitivity to EGFR tyrosine kinase inhibitors (TKIs). While in-frame deletion in exon 19 (Del19) and a point mutation (L858R) in exon 21 are the two most common sensitizing EGFR mutations in NSCLC, approximately 10% of EGFR mutation-positive tumors harbor uncommon mutations.

These mutations represent a heterogeneous group of rare molecular alterations (or combinations) within exons 18-21, whose oncogenicity and sensitivity to EGFR TKIs may vary and has not been prospectively studied. Recently, a retrospective analysis reported that overall response rate of EGFR TKI (gefitinib or erlotinib) treatment was about 10% or less in Korean NSCLC patients with uncommon EGFR mutation other than del19, L858R and T790M \[11\]. In preclinical data, the potency of AZD9291 against uncommon EGFR mutants other than exon 20 insertion mutation was fairly good.

Based on the result, in this study, we try to evaluate the efficacy of AZD9291, the potent irreversible inhibitor, in NSCLC patients with harboring uncommon EGFR mutations.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09).
   Cho JH, Lim SH, An HJ, Kim KH, et al · · 2020 · cited 271× · PMID 31825714 · DOI 10.1200/jco.19.00931
2. Afatinib treatment response in advanced lung adenocarcinomas harboring uncommon mutations.
   Li T, Wang S, Ying J, Wang Y, et al · · 2021 · cited 19× · PMID 34549528 · DOI 10.1111/1759-7714.14156
3. Iterative Upgrading of Small Molecular Tyrosine Kinase Inhibitors for EGFR Mutation in NSCLC: Necessity and Perspective.
   Zhu J, Yang Q, Xu W. · · 2021 · cited 11× · PMID 34575576 · DOI 10.3390/pharmaceutics13091500