Actively Recruiting
Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations
Led by Peking Union Medical College Hospital · Updated on 2024-11-05
144
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
CONDITIONS
Official Title
Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older, male or female
- Histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma not suitable for curative surgery or radiotherapy
- Confirmed EGFR mutation 19Del or L858R (single or compound) by local laboratory
- No prior systemic antitumor therapy for locally advanced or metastatic NSCLC
- At least one measurable lesion per RECIST 1.1, with biopsy rules for single lesion
- Adequate organ function shown by laboratory tests including ANC, platelets, hemoglobin, liver enzymes, bilirubin, and kidney function
- ECOG performance status of 0-1 with no disease worsening in 2 weeks before screening
- Life expectancy longer than 12 weeks after first dose
- Female participants of childbearing potential are not pregnant and agree to contraception during and 6 months after study
- Ability to understand and voluntarily consent to the study
You will not qualify if you...
- NSCLC with predominant squamous cell histology, small cell lung cancer, or neuroendocrine carcinoma
- Presence of other driver gene mutations such as ALK, ROS1, RET, BRAF, NTRK, MET, KRAS (excluding TP53, RB1, BRAC mutations)
- Planned or expected anti-tumor therapy other than study drug during trial
- Recent irradiation of more than 30% bone marrow or large area within 4 weeks before study
- Major surgery within 4 weeks before study or planned major surgery during study except specific procedures
- Use of potent CYP3A4 inhibitors or inducers shortly before study start
- Use of traditional Chinese medicine with tumor indication or anti-tumor effects shortly before or during study
- Recent participation in clinical trials with investigational products
- Anti-tumor drugs within 14 days before study start
- Symptomatic brain metastases or spinal cord compression
- Unresolved toxicity from prior anti-tumor therapy above grade 1 except alopecia or specific sequelae
- Unstable pleural or peritoneal effusion with symptoms
- History of other malignant tumors except certain treated cancers without recurrence within 5 years
- Previous interstitial lung disease or radiation pneumonitis requiring steroids
- Severe or uncontrolled systemic diseases including hypertension, diabetes, heart failure, unstable angina, recent myocardial infarction, bleeding disorders
- QTc interval over 470 ms or significant arrhythmias
- Serious gastrointestinal problems affecting drug intake
- Infectious disease requiring intravenous treatment
- History of mental illness or drug abuse currently active or under treatment
- Allergy to furmonertinib or its components
- Pregnant or lactating females or partners planning pregnancy
- Poor compliance or inability to follow study procedures
- Other conditions judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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