Actively Recruiting
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
Led by Peking Union Medical College Hospital · Updated on 2025-12-02
18
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, single-arm phase II clinical study to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for HER2-mutated or amplified non-small cell lung cancer. Pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.
CONDITIONS
Official Title
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed stage IIIB or IV non-small cell lung cancer
- No prior systemic anticancer therapy for stage IIIB or IV NSCLC
- Confirmed HER2 insertion mutation, primary HER2 point mutation, or primary HER2 amplification by genetic testing of tumor tissue or other samples
- At least one measurable lesion based on RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Left ventricular ejection fraction (LVEF) 50% or higher by cardiac ultrasound
- Adequate bone marrow, liver, and kidney function as shown by laboratory tests before first treatment, including:
- Neutrophil count (ANC) 1500/mm3 or higher
- Platelet count 75,000/mm3 or higher
- Hemoglobin 8 g/dL or higher
- Serum creatinine within 1.5 times the upper limit of normal or creatinine clearance 60 mL/min or higher
- Total bilirubin within 1.5 times the upper limit of normal
- AST or ALT less than or equal to 2.5 times the upper limit of normal (up to 5 times if liver metastases present)
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Previous treatment with EGFR tyrosine kinase inhibitors
- Participation in other drug clinical trials within 4 weeks before study start
- Symptomatic brain or meningeal metastases
- Insufficient bone marrow reserve or organ function
- Severe nausea, vomiting, chronic gastrointestinal diseases or inability to swallow medications
- Major surgery, severe trauma, fractures, or poorly healing wounds within 4 weeks
- History of other cancers unless disease-free for at least 3 years after potentially curative therapy (exceptions include certain skin and bladder cancers)
- Serious allergies or adverse reactions to study drugs or excipients
- Pregnant or breastfeeding women, women of childbearing potential unwilling to use effective contraception during the study
- Serious concurrent diseases or any condition judged unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College
Beijing, Beijing Municipality, China, 100000
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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