Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy … (NCT07365410) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study
China60 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* N…
What they're measuring
1
Median Progression-Free Survival (PFS) as assessed by Investigator
Timeframe: Approximately 18 months after the first patient begin study treatment
Trial details
NCT IDNCT07365410
SponsorTianjin Medical University Cancer Institute and Hospital