Actively Recruiting
High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI
Led by Jialei Wang · Updated on 2025-11-21
60
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label,randomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKI.Eligible patients will randomly be assigned in a 1:1:1 ratio to receive 160mg/240mg furmonertinib p.o qd or 160mg furmonertinib p.o qd plus chemotherapy\[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance\].Patients will be followed up every 2 cycles during the first half year , and every 3 cycles after the first half year.Treatment was continued until disease progression,intolerable toxic effects, investigator decision, patient withdrawal of consent, or death, whichever occurred first.
CONDITIONS
Official Title
High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have locally advanced or metastatic non-small cell lung cancer
- Have confirmed EGFR-sensitive mutations by histology or hematology
- Experienced disease progression after first-line treatment with third-generation EGFR-TKI monotherapy
- Received Osimertinib or Almonertinib for at least 3 months before progression or Furmonertinib for at least 6 months with remission or clinical benefit
- If previously received chemotherapy or immunotherapy as neoadjuvant or adjuvant therapy, metastatic or recurrent disease occurred more than 6 months after last treatment
- Have at least one measurable lesion not previously irradiated or biopsied (or biopsy permitted if minimal impact on lesion detection)
- Be 18 years or older
- Have ECOG performance status of 0 or 1 without worsening within 2 weeks prior to enrollment
- Have a life expectancy of at least 12 weeks
- Female patients of reproductive age must have a negative pregnancy test within 7 days before first medication
- Able to comply with study protocols
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Tumor contains small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma component exceeding 10%
- Presence of other known driver gene mutations with available therapies (e.g., MET amplification, RET fusion, BRAF V600E mutation)
- Known or suspected allergy to study drug or its components
- Received any systemic anti-tumor therapy other than third-generation EGFR-TKI prior to study drug or cytotoxic drugs with delayed toxicity within 6 weeks before first dose
- Received non-specific immunomodulators, Chinese medicine with anti-tumor indications within 2 weeks prior to initial administration
- Taken potent CYP3A4 inhibitors or inducers within 7 days prior to initial study drug or require continued treatment with these during study
- Chest radiation therapy over 30 Gy within 6 months prior to dosing or non-thoracic radiation over 30 Gy within 4 weeks prior
- Received intrapleural perfusion less than 28 days before enrollment
- Major surgery within 28 days before first dose
- Conditions increasing risk of QTc prolongation or ventricular tachycardia, or taking medications prolonging QT interval during study
- Toxicity from prior therapy not recovered to CTCAE Class 1, except hair loss or mild peripheral neurotoxicity
- Spinal cord compression or symptomatic central nervous system metastasis; asymptomatic stable CNS metastases must be off steroids for at least 14 days
- Other malignant tumors within last 5 years, except certain controlled skin or cervical cancers
- Active peptic diseases or severe gastrointestinal conditions that may cause bleeding or perforation
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, diabetes, active bleeding, hepatitis B or C, or HIV infection
- Past or suspected interstitial lung disease not ruled out by imaging
- Severe pulmonary complications or autoimmune diseases involving lungs
- Known corneal injury
- Inadequate bone marrow or organ function within 28 days prior to first dose
- Cardiac conditions including QTc >470 ms, significant ECG abnormalities, heart failure, or recent myocardial infarction
- Investigator judgment of inability to comply with study requirements
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, China, 021
Actively Recruiting
Research Team
J
Jialei Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here