Osimertinib + Telaglenastat RP2D Identified for EGFR-Mutated Stage IV NSCLC

Trial results for the combination of osimertinib and telaglenastat hydrochloride in treating patients with EGFR-mutated Stage IV non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-06-19. The study identified the Recommended Phase II Dose (RP2D) for the combination, with telaglenastat hydrochloride at 800 milligrams and osimertinib at 80 milligrams.

Background

This Phase 1b trial investigated the combination of telaglenastat hydrochloride and osimertinib. The study's objective was to determine the side effects and optimal dose of this combination in patients with Stage IV non-small cell lung cancer who have a mutation in the EGFR gene. Both agents are believed to stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Trial design

The study (NCT03831932) was a Phase 1b/2 trial that enrolled 22 participants. It focused on patients diagnosed with Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, and Stage IV Lung Cancer AJCC v8, specifically those with an EGFR gene mutation. The trial investigated the use of osimertinib in combination with telaglenastat hydrochloride.

Key results

The trial identified the Recommended Phase II Dose (RP2D) for the combination therapy during its Phase 1b cohorts. The RP2D was determined to be 800 milligrams for telaglenastat hydrochloride and 80 milligrams for osimertinib.

What this means

The identification of the Recommended Phase II Dose for the combination of osimertinib and telaglenastat hydrochloride is a crucial step for the continued development of this therapeutic approach. Establishing a safe and tolerable dose allows for progression to further phases of clinical investigation, where the efficacy of this combination can be more thoroughly evaluated in patients with EGFR-mutated Stage IV non-small cell lung cancer.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03831932, titled "Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer," were posted on 2025-06-19 on clinicaltrials.gov.