NCT04785742

Almonertinib for Advanced NSCLC Patients With Rare Mutations in EGFR

Status unknown Phase 2 Last updated 8 March 2021

What this trial tests

Phase 2 trial testing Almonertinib in Safety of Almonertinib in 40 participants. Status unknown.

Timeline

31 December 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	40
Start date	31 December 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• Almonertinib — full drug profile →

Conditions studied

• Safety of Almonertinib — all drugs for Safety of Almonertinib →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Safety of Almonertinib. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open, phase II clinical trial evaluating the safety and efficacy of high-dose almonertinib in the treatment of rare mutations in locally advanced or metastatic NSCLC patients with EGFR mutations (excluding exon 19 deletion or rare mutations outside L858R). Patients showed EGFR mutations by tissue or blood tests (excluding exon 19 deletion or rare mutations other than L858R), of which 20 exon (20INS) mutations and rare mutations other than 20Ins were classified as two covariates. High-dose amitinib was used for treatment to evaluate the safety and efficacy of the treatment regimen.

Publications & conference data

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

1. Structural Insight and Development of EGFR Tyrosine Kinase Inhibitors.
   Amelia T, Kartasasmita RE, Ohwada T, Tjahjono DH. · · 2022 · cited 83× · PMID 35164092 · DOI 10.3390/molecules27030819
2. <i>EGFR</i> uncommon alterations in advanced non-small cell lung cancer and structural insights into sensitivity to diverse tyrosine kinase inhibitors.
   Xu H, Yang G, Liu R, Yang Y, et al · · 2022 · cited 9× · PMID 36188595 · DOI 10.3389/fphar.2022.976731
3. Successful treatment of lung adenocarcinoma complicated with a rare compound <i>EGFR</i> mutation L833V/H835L using aumolertinib: a case report and literature review.
   Li L, Huang S, Qin L, Yan N, et al · · 2023 · cited 4× · PMID 37719840 · DOI 10.3389/fphar.2023.1257592