Actively Recruiting
A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases
Led by Allist Pharmaceuticals, Inc. · Updated on 2026-02-12
380
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing mutation-positive non-squamous non-small cell lung cancer (NSCLC) and brain metastases. Additionally, a proportion of subjects will receive furmonertinib monotherapy (Arm C) to further explore its efficacy and safety profile. Stage 1 is the safety run-in phase, planned to enroll approximately 30 subjects who will be randomized at a 1:1 ratio to receive either furmonertinib 80 mg QD plus platinum-based chemotherapy or furmonertinib 160 mg QD plus platinum-based chemotherapy, aiming to evaluate the safety and tolerability of different furmonertinib doses in combination with platinum-based chemotherapy. Stage 2 is the randomized controlled phase, in which approximately 350 subjects will be randomized in a 3:3:1 ratio (Arm A : Arm B : Arm C) to receive the investigational treatments.
CONDITIONS
Official Title
A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Histologically or cytologically confirmed non-squamous NSCLC with brain parenchymal metastases
- Clinically stable brain metastases for at least 4 weeks before first dose
- No corticosteroids or anticonvulsants needed for at least 14 days before first dose
- Confirmed EGFR sensitizing mutations (ex19del or L858R) via tumor tissue, cytology, or blood testing
- No prior systemic anti-tumor therapy for advanced or metastatic NSCLC; prior (neo)adjuvant chemotherapy or chemoradiotherapy allowed if at least 6 months since completion
- At least one measurable intracranial and extracranial lesion per RECIST v1.1 without prior local treatment
- ECOG performance status 0-1 without deterioration within 2 weeks prior to first dose
- Life expectancy of at least 3 months
- Adequate bone marrow and organ function without recent transfusions or growth factors
- All prior treatment toxicities resolved to Grade 1 or lower except alopecia or peripheral neuropathy up to Grade 2
- Women of childbearing potential must have negative pregnancy test, be non-lactating, and use effective contraception from consent until 6 months after last dose; males with fertile partners must use contraception during same period
You will not qualify if you...
- Tumor with more than 10% neuroendocrine, sarcomatoid, or squamous cell carcinoma components
- Known positive for ALK, ROS1, RET, NTRK fusions, BRAF V600 mutation, MET exon 14 skipping, or other approved targeted mutations
- Meningeal metastasis without brain parenchymal metastasis
- Prior systemic anti-tumor therapy targeting EGFR or for advanced/metastatic NSCLC
- Recent high-dose chest radiotherapy or brain radiotherapy
- Use of certain immune modulators or CYP3A4 strong inhibitors/inducers before first administration
- Other active malignancies except certain treated cancers or cured malignancies over 3 years
- Brain stem metastasis, spinal cord metastasis, or compression; acute or progressive intracranial hypertension symptoms
- Grade 2 or higher neurological symptoms from brain metastases uncontrolled by steroids or anticonvulsants
- Tumor invading critical organs or vessels with fistula risk
- Cardiovascular or cerebrovascular disease or risk factors
- Uncontrolled systemic diseases or severe infections
- History of interstitial lung disease or severe lung damage
- Long-term corticosteroid or immunosuppressive therapy before first administration
- Recent major surgery or significant bleeding tendency
- Severe gastrointestinal dysfunction
- Known allergy to study drug ingredients
- Pregnant or lactating women or planning pregnancy during or within 6 months after study
- Other conditions compromising safety or study results as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangdong, Guangzhou, China
Actively Recruiting
Research Team
S
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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