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Clinical Trials/NCT07365410
NCT07365410
Not yet recruiting
Phase 2

Furmonertinib 160mg Versus Furmonertinib 80mg Combined With Chemotherapy (Carboplatin + Pemetrexed) as First-Line Treatment for EGFR-Mutated NSCLC Patients With Brain Metastases: A Multicenter Study of Efficacy and Safety

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country60 target enrollmentStarted: January 1, 2026Last updated:
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InterventionsFurmonertinibcarboplatinpemetrexed

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Median Progression-Free Survival (PFS) as assessed by Investigator
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •IInclusion Criteria
  • •Aged 18 to 75 years (male or female)
  • •Histopathologically confirmed, unresectable, and non-radiocurable newly -diagnosed locally advanced or metastatic lung adenocarcinoma
  • •Confirmed by local laboratory to have one of the following EGFR mutations: -19Del or L858R (single or mixed mutations are allowed)
  • •Treatment-naive for locally advanced (not suitable for surgery/radiotherapy per investigator) or metastatic NSCLC; adjuvant/neoadjuvant therapy completed \>6 months before first progression is allowed (≤6 months is considered pretreated)
  • •At least one measurable tumor lesion per RECIST 1.1 (lesions previously treated with radiotherapy are excluded; if only one measurable lesion exists, biopsy is allowed but baseline imaging must be performed ≥14 days after biopsy)
  • •Confirmed stable and asymptomatic brain metastases
  • •Sufficient organ function (per laboratory tests): ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, HGB ≥90g/L; TBIL ≤1.5×ULN, AST/ALT ≤2.5×ULN (for liver metastasis: TBIL ≤3×ULN, AST/ALT ≤5×ULN); CrCL ≥50 ml/min (Cockcroft-Gault formula)
  • •ECOG performance status 0-2 (no significant disease deterioration in 2 weeks before screening)
  • •Expected survival \>12 weeks after first dose

Exclusion Criteria

  • •NSCLC with predominantly squamous cell histology, small cell lung cancer, neuroendocrine carcinoma, or other non-adenocarcinoma histologies
  • •Concurrent positive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation); TP53, RB1, and BRAC mutations are excluded
  • •Expected to receive other anti-tumor therapies during the trial
  • •Major surgery (except vascular access or biopsy) within 4 weeks before first dose or planned during the trial
  • •Use of CYP3A4 strong inhibitor within 7 days or strong inducer within 21 days before first dose; use of anti-tumor Chinese medicine within 2 weeks before first dose or planned during the trial
  • •Participation in other clinical trials (investigational drug/device) within 4 weeks or 5 half-lives before first dose
  • •Use of other anti-tumor drugs within 14 days before first dose
  • •Spinal cord compression or symptomatic leptomeningeal metastasis
  • •Toxicity from previous anti-tumor therapy not recovered to ≤CTCAE Grade 1 (except alopecia or platinum-induced peripheral neuropathy)
  • •Symptomatic or unstable pleural/peritoneal effusion (stable ≥14 days after drainage is allowed)

Arms & Interventions

Furmonertinib 160mg Group

Experimental

Participants receive oral furmonertinib 160mg once daily as first-line treatment.

Intervention: Furmonertinib (Drug)

Furmonertinib 80mg + Chemotherapy Group

Active Comparator

Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.

Intervention: Furmonertinib (Drug)

Furmonertinib 80mg + Chemotherapy Group

Active Comparator

Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.

Intervention: carboplatin (Drug)

Furmonertinib 80mg + Chemotherapy Group

Active Comparator

Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.

Intervention: pemetrexed (Drug)

Outcomes

Primary Outcomes

Median Progression-Free Survival (PFS) as assessed by Investigator

Time Frame: Approximately 18 months after the first patient begin study treatment

The time from the first dose of the study drug to the progression of the disease (Investigator-Assessed) or death for any reason according to investigator.

Secondary Outcomes

  • Objective Response Rate (ORR) as assessed by RECIST 1.1(Approximately 12 weeks following the first dose of study drug)
  • Disease Control Rate (DCR) as assessed by RECIST 1.1(Approximately 18 months from the first patient begin study treatment)
  • Central Nervous System (CNS) Objective Response Rate (CNS ORR) as assessed by RECIST 1.1(Approximately 12 weeks after the first dose of study drug)
  • Central Nervous System (CNS) Disease Control Rate (CNS DCR) as assessed by RECIST 1.1(Approximately 18 months after the first dose of study drug)
  • Central Nervous System Progression-Free Survival (CNS PFS) as assessed by RECIST 1.1(Approximately 18 months after the first dose of study drug)
  • Median Overall Survival (OS)(Approximately 24 months after the first dose of study drug)
  • Safety Profile (Adverse Events, AE) as assessed by CTCAE v5.0(From the start of study drug to 28 days after the last dose of study drug)
  • Progression Pattern as assessed by RECIST 1.1 and Clinical Evaluation(Approximately 18 months after the first dose of study drug)
  • Site Analysis of Disease Progression as assessed by RECIST 1.1 and Clinical Evaluation(Approximately 18 months after the first dose of study drug)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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