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

January 23, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Non-pregnant women of childbearing potential (no pregnancy plan); women and men agree to use effective contraception during the study and 6 months after drug discontinuation
  • Voluntarily signs informed consent and understands the study procedures Exclusion Criteria（排除标准）
  • 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)
  • History of other malignancies (except cured malignancies with no recurrence in 5 years: cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma)
  • History of interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or suspected ILD
  • Uncontrolled severe systemic diseases (e.g., hypertension, diabetes, NYHA III-IV heart failure, unstable angina, myocardial infarction within 1 year, active bleeding)
  • QTc >470 msec on resting ECG
  • Clinically significant QT prolongation or arrhythmias increasing QT risk (e.g., complete left bundle branch block, III° AV block, congenital long QT syndrome, severe hypokalemia, use of drugs causing QT prolongation)
  • Severe gastrointestinal dysfunction that impairs drug intake or absorption Infections requiring intravenous medication
  • Active mental illness or drug addiction
  • Known or suspected allergy to furmonertinib or its components
  • Pregnant or lactating women; women or their partners planning pregnancy during the study
  • Poor compliance (unable to follow study procedures)
  • Other conditions deemed unsuitable for enrollment by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Furmonertinib 160mg Group
Participants receive oral furmonertinib 160mg once daily as first-line treatment.
Drug: Furmonertinib
Oral administration, 160mg once daily.
Drug: Furmonertinib
Oral administration, 80mg once daily
Active Comparator: Furmonertinib 80mg + Chemotherapy Group
Participants receive oral furmonertinib 80mg once daily combined with intravenous carboplatin + pemetrexed (cycle-based) as first-line treatment.
Drug: Furmonertinib
Oral administration, 160mg once daily.
Drug: Furmonertinib
Oral administration, 80mg once daily
Drug: carboplatin
Intravenous infusion, cycle-based (per study protocol).
Drug: pemetrexed
Intravenous infusion, cycle-based (per study protocol).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 18 months after the first patient begin study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) as assessed by RECIST 1.1
Time Frame: Approximately 12 weeks following the first dose of study drug
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Approximately 12 weeks following the first dose of study drug
Disease Control Rate (DCR) as assessed by RECIST 1.1
Time Frame: Approximately 18 months from the first patient begin study treatment
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to 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
Time Frame: Approximately 12 weeks after the first dose of study drug
Proportion of subjects whose central nervous system (CNS) tumors (including intracranial parenchymal metastases and asymptomatic meningeal metastases as defined in the inclusion criteria) are assessed as Complete Response (CR) or Partial Response (PR) according to RECIST1.1.
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
Time Frame: Approximately 18 months after the first dose of study drug
Proportion of subjects whose central nervous system (CNS) tumors (including intracranial parenchymal metastases and asymptomatic meningeal metastases as defined in the inclusion criteria) are assessed as Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to 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
Time Frame: Approximately 18 months after the first dose of study drug
The time from the first dose of the study drug (Furmonertinib) to the first occurrence of central nervous system (CNS) disease progression (assessed by RECIST 1.1) or death from any cause, whichever comes first.
Approximately 18 months after the first dose of study drug
Median Overall Survival (OS)
Time Frame: Approximately 24 months after the first dose of study drug
The time from the first does of the study drugs to the death for any reason
Approximately 24 months after the first dose of study drug
Safety Profile (Adverse Events, AE) as assessed by CTCAE v5.0
Time Frame: From the start of study drug to 28 days after the last dose of study drug
The number of patients with adverse events and the severity grading (Grade 1-5) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
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
Time Frame: Approximately 18 months after the first dose of study drug
Proportion of subjects with first disease progression classified as Intracranial, extracranial, or combined intracranial-extracranial progression.
Approximately 18 months after the first dose of study drug
Site Analysis of Disease Progression as assessed by RECIST 1.1 and Clinical Evaluation
Time Frame: Approximately 18 months after the first dose of study drug
Frequency of specific progression sites.
Approximately 18 months after the first dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E20250722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) to be shared include demographic characteristics, clinical baseline data (e.g., ECOG PS score, EGFR mutation status, brain metastasis status), efficacy endpoints (median PFS, ORR, DCR, CNS ORR, CNS DCR, CNS PFS, OS) assessed by RECIST 1.1, adverse event data graded by CTCAE v5.0, progression pattern and site data, and biomarker (NGS) data collected at baseline and disease progression. The data will be made available after the completion of the primary analysis (expected by December 2028) for non-commercial scientific research purposes, to support further exploration of EGFR-mutated NSCLC with brain metastasis treatment.

IPD Sharing Time Frame

Available from June 2029 (after completion of primary analysis) to December 2034 (5 years after data availability).

IPD Sharing Access Criteria

Researchers interested in accessing the IPD must submit a formal research proposal to the leading research unit (Tianjin Medical University Cancer Institute and Hospital) and the sponsor for review. Approval will be granted based on the scientific merit of the proposal, alignment with the study's objectives, and compliance with data privacy and ethical requirements. A data use agreement (DUA) must be signed prior to data access, prohibiting re-identification of participants and restricting data use to non-commercial research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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