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Compares treatment options for NSCLC Patients With Brain Metastasis
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
ClinicalTrials.gov ID: NCT06970639
What this study is testing
What is Furmonertinib Mesilate Tablets?
Furmonertinib Mesilate Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nsclc patients with brain metastasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Fully understand the trial and voluntarily sign the informed consent form;
- Age ≥18 years at the time of signing ICF, regardless of gender;
- Histologically/cytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; people with both brain parenchymal and...
- For people with brain metastases: clinically stable for ≥4 weeks prior to first dose AND no requirement for corticosteroids/anticonvulsants for ≥14...
- Confirmed EGFR sensitizing mutations (ex19del or L858R) via tumor tissue/cytology/blood testing;
You likely can't join if
- The tumor histology or cytology confirmed that the combination of neuroendocrine carcinoma, sarcomatoid carcinoma or squamous cell carcinoma was more...
- Known people with ALK positive, ros1 positive, RET fusion positive, ntrk fusion positive, BRAF V600 mutation, met exon 14 skipping variant and other...
- people with meningeal metastasis but no brain parenchymal metastasis confirmed by MRI and / or CSF malignant cell examination;
- people who have previously received any of the following treatments:
- Have received any systemic anti-tumor therapy targeting EGFR in the past, including those in clinical research stage (including EGFR TKI, monoclonal...
- Previously received systemic antitumor therapy (such as chemotherapy, targeted therapy, immunotherapy, etc.) for locally advanced / metastatic...
See the full eligibility criteria
Who can join
- Fully understand the trial and voluntarily sign the informed consent form;
- Age ≥18 years at the time of signing ICF, regardless of gender;
- Histologically/cytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; people with both brain parenchymal and leptomeningeal metastases are eligible. people without brain...
- For people with brain metastases: clinically stable for ≥4 weeks prior to first dose AND no requirement for corticosteroids/anticonvulsants for ≥14 days prior to first dose; Investigator-confirmed no need for local...
- Confirmed EGFR sensitizing mutations (ex19del or L858R) via tumor tissue/cytology/blood testing;
- No prior systemic anti-tumor therapy for advanced/metastatic NSCLC; people who received (neo)adjuvant chemotherapy or definitive chemoradiotherapy must have disease recurrence/progression ≥6 months after completion;
- ≥1 measurable intracranial AND extracranial lesion(s) per RECIST v1.1 without prior local treatment;
- ECOG PS 0-1 with no deterioration within 2 weeks prior to first dose, and life expectancy ≥3 months;
- Adequate bone marrow and organ function (no transfusion/G-CSF within 2 weeks prior to first dose);
- All prior treatment-related toxicities resolved to ≤Grade 1 (per NCI CTCAE v5.0) except alopecia (≤Grade 2) or peripheral neuropathy (≤Grade 2);
- Women of childbearing potential (WOCBP) must have negative serum pregnancy test within 7 days prior to first dose, be non-lactating, and use effective contraception from ICF signing until 6 months after last dose. Male...
What rules you out
- The tumor histology or cytology confirmed that the combination of neuroendocrine carcinoma, sarcomatoid carcinoma or squamous cell carcinoma was more than 10%;
- Known people with ALK positive, ros1 positive, RET fusion positive, ntrk fusion positive, BRAF V600 mutation, met exon 14 skipping variant and other approved drugs for this target;
- people with meningeal metastasis but no brain parenchymal metastasis confirmed by MRI and / or CSF malignant cell examination;
- people who have previously received any of the following treatments:
- Have received any systemic anti-tumor therapy targeting EGFR in the past, including those in clinical research stage (including EGFR TKI, monoclonal antibody, bispecific antibody, etc.);
- Previously received systemic antitumor therapy (such as chemotherapy, targeted therapy, immunotherapy, etc.) for locally advanced / metastatic non-small cell lung cancer;
- Received \> 30 Gy of chest radiotherapy within 6 months before the first dose; Received non thoracic radiotherapy of \>30 Gy within 4 weeks before the first dose; Received palliative radiotherapy ≤ 30Gy within 2 weeks...
- Chinese patent medicine that has received non-specific immune modulators (including but not limited to interferon and IL-2) and approved anti-tumor indications within 2 weeks before the first administration;
- Have used any strong inhibitor of cytochrome P450 3A4 (CYP3A4) within 7 days before the first administration or any strong inducer of CYP3A4 within 21 days before the first administration;
- Other malignant tumors in addition to the primary tumor; Skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid cancer...
- Brain metastasis people with known brain stem metastasis, spinal cord metastasis and / or compression; people with acute or progressive intracranial hypertension related symptoms during the screening period; people with...
- According to CTCAE 5.0, there were people with grade 2 headache, vomiting, papilledema, etc. caused by increased intracranial pressure during the screening period; people with grade 2 sensory / motor impairment and...
- The tumor invades the surrounding important organs and blood vessels (such as the heart, esophagus, superior vena cava, etc.) or has the risk of esophago tracheal fistula or esophago pleural fistula;
- Cardiovascular and cerebrovascular disease or cardiovascular and cerebrovascular risk factors exist.
- There are uncontrollable systemic diseases.
- There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment.
- Pulmonary complications lead to clinically severe lung damage.
- Severe acute or chronic infection
- people who are receiving long-term systemic corticosteroid therapy with prednisone \> 10 mg/d or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy before the first administration [people...
- people who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study;
- Bleeding symptoms with significant clinical significance or obvious bleeding tendency within 4 weeks before the first administration.
- Severe gastrointestinal dysfunction is known.
- Known or suspected allergy to the ingredients of the study drug or its analogues;
- Pregnant or lactating women or female people who plan to become pregnant during the study or within 6 months after the last dose;
- In the judgment of the investigator, the subject has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, suffering from other serious...
The study team makes the final eligibility decision.
Where it's taking place
- Guangdong, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangdong, Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.