NCT04438902

Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment

Terminated Phase 2 Last updated 21 February 2023

What this trial tests

Phase 2 trial testing osimertinib mesylate tablets and anlotinib hydrochloride capsules in Non Small Cell Lung Cancer in 3 participants. Terminated before completion.

Timeline

12 December 2020

Primary endpoint
8 December 2022

16 February 2023

Quick facts

Lead sponsor	First Affiliated Hospital of Zhejiang University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	12 December 2020
Primary completion	8 December 2022
Estimated completion	16 February 2023
Sites	2 locations across China

Drugs / interventions tested

• osimertinib mesylate tablets and anlotinib hydrochloride capsules — full drug profile →

Conditions studied

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

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

Adults 18 to 75, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

EGFR T790M gatekeeper mutation accounts for approximately 60% of acquired resistance to the first- or second-generation EGFR-TKI treatment. Osimertinib, a third-generation EGFR TKI, has become the standard therapy for NSCLC patients with acquired EGFR T790M mutation. However, acquired resistance to osimertinib is still inevitable and there is no established targetable agent currently. Thus, treatment strategy for patients with acquire resistance to osimertinib remains an urgent issue. In this study, we aimed to evaluate the efficacy of osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.

Publications & conference data

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

1. Acquired Resistance to Osimertinib in <i>EGFR</i>-Mutated Non-Small Cell Lung Cancer: How Do We Overcome It?
   Bertoli E, De Carlo E, Del Conte A, Stanzione B, et al · · 2022 · cited 34× · PMID 35805940 · DOI 10.3390/ijms23136936
2. Osimertinib in EGFR-Mutated Lung Cancer: A Review of the Existing and Emerging Clinical Data.
   Lee CS, Milone M, Seetharamu N. · · 2021 · cited 24× · PMID 34471361 · DOI 10.2147/ott.s227032
3. Combination of Osimertinib and Anlotinib May Overcome the Resistance Mediated by in cis <i>EGFR</i> T790M-C797S in NSCLC: A Case Report.
   Zhou R, Song L, Zhang W, Shao L, et al · · 2021 · cited 14× · PMID 33958875 · DOI 10.2147/ott.s298655
4. Salvage therapy of osimertinib plus anlotinib in advanced lung adenocarcinoma with leptomeningeal metastasis: A case report.
   Wu K, Fu Y, Gao Z, Jiang J. · · 2022 · cited 1× · PMID 35707406 · DOI 10.1016/j.rmcr.2022.101682