A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases

This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing mutation-positive non-squamous non-small cell lung cancer (NSCLC) and brain metastases. Additionally, a proportion of subjects will receive furmonertinib monotherapy (Arm C) to further explore its efficacy and safety profile. Stage 1 is the safety run-in phase, planned to enroll approximately

Trial Details

NCT ID

NCT06970639

Phase

PHASE3

Sponsor

Allist Pharmaceuticals, Inc.

Status

RECRUITING

Cancer Type

Brain Cancer

Locations (sample)

• Guangdong, Guangzhou, China

Key Eligibility Criteria

• Fully understand the trial and voluntarily sign the informed consent form;
• Age ≥18 years at the time of signing ICF, regardless of gender;
• Histologically/cytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; Subjects with both brain parenchymal …
• For subjects with brain metastases: clinically stable for ≥4 weeks prior to first dose AND no requirement for corticosteroids/anticonvulsants for ≥…

For full eligibility, visit ClinicalTrials.gov.

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