Trial intelligence / Profile preview

Almonertinib Dose Exploration in EGFR-Mutant NSCLC with CNS Metastases

NCT04778800Phase 2

Key facts

Status: Unknown
Start: Mar 2021
Primary completion: Feb 2023
Countries: 1
Sponsor: Henan Cancer Hospital
Modality: Small Molecules

Drugs: almonertinib
Conditions: non-small cell lung cancer (NSCLC)brain metastasesleptomeningeal metastases (LM)

Overview

Phase 2, open-label trial of almonertinib in non-small cell lung cancer (NSCLC), brain metastases and leptomeningeal metastases (LM) (3 arms), sponsored by Henan Cancer Hospital. Primary endpoint: Intracranial Progression-Free Survival at 3 years. Status: unknown.

Design

3 arms

Study design: Non-randomizedOpen-label

Almonertinib 110mg (Brain Mets)
Almonertinib 110mg daily. Escalate to 165mg if brain progression occurs while systemic disease is stable.
Almonertinib 160mg (LM 1st Line)
Almonertinib 110mg daily. Escalate to 165mg then 220mg if no progression.
Almonertinib 220mg (LM 2nd Line)
Almonertinib 110mg daily. Escalate to 165mg then 220mg if no progression.

Who it enrols

Patients with histologically confirmed NSCLC and EGFR sensitive mutations (Exon 19 deletion or L858R). Must have brain metastases (Queue 1) or leptomeningeal metastases (Queue 2/3). Queue 1 and 2 are for patients who have not received other systemic treatment or have relapsed. Queue 3 is for patients with brain progression after 1st/2nd generation EGFR-TKI.

Endpoints

Primary

Intracranial Progression-Free Survival3 years

Secondary

Disease Control Rate3 years
Progression-Free Survival3 years
Overall Survival3 years

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