Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07365410
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Brain Metastases
  • EGFR Mutation
  • Furmonertinib
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Furmonertinib — DRUG
    Oral administration, 160mg once daily.
  • Furmonertinib — DRUG
    Oral administration, 80mg once daily
  • carboplatin — DRUG
    Intravenous infusion, cycle-based (per study protocol).
  • pemetrexed — DRUG
    Intravenous infusion, cycle-based (per study protocol).

Study Details

This multicenter study evaluates the efficacy and safety of furmonertinib 160mg versus furmonertinib 80mg plus chemotherapy (carboplatin + pemetrexed) as first-line treatment for EGFR-mutated NSCLC patients with brain metastases. It aims to determine which approach is more effective and safer.

Key Dates

Start date
Jan 31, 2026
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Furmonertinib 160mg Group
    Participants receive oral furmonertinib 160mg once daily as first-line treatment.
  • Active Comparator: Furmonertinib 80mg + Chemotherapy Group
    Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.

Primary Outcome Measure

Median Progression-Free Survival (PFS) as assessed by Investigator [ Time Frame: Approximately 18 months after the first patient begin study treatment ]

Central Contacts

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