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

NCT07365410 | Not Yet Recruiting Phase 2

• 1 other identifier: E20250722
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (9)

• 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

Study Arms (2)

Furmonertinib 160mg Group

EXPERIMENTAL

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

Drug: Furmonertinib

Furmonertinib 80mg + Chemotherapy Group

ACTIVE COMPARATOR

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

Drug: Furmonertinib; Drug: carboplatin; Drug: pemetrexed

Interventions

Furmonertinib DRUG

Oral administration, 160mg once daily.

Furmonertinib 160mg Group

carboplatin DRUG

Intravenous infusion, cycle-based (per study protocol).

Furmonertinib 80mg + Chemotherapy Group

pemetrexed DRUG

Intravenous infusion, cycle-based (per study protocol).

Furmonertinib 80mg + Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

aflutinib; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Dingzhi Huang Huang

CONTACT

+86-22-23340123-1031; dingzhih72@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Available from June 2029 (after completion of primary analysis) to December 2034 (5 years after data availability).
• 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.

Locations

CN (1)