Using pyrotinib to treat advanced HER2-positive non-small cell lung cancer

Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer

This study is testing if a new drug called pyrotinib can help people with advanced HER2-positive non-small cell lung cancer feel better as a first treatment option.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: pyrotinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05751018 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm phase II clinical study aims to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for patients with HER2-amplified or mutated advanced non-small cell lung cancer (NSCLC). Pyrotinib is a small molecule tyrosine kinase inhibitor that targets HER1, HER2, and HER4, potentially offering a new therapeutic option for this patient population. Participants must have histologically confirmed stage IIIB or IV NSCLC and meet specific eligibility criteria, including measurable lesions and adequate organ function. The study will assess treatment outcomes and side effects to determine the drug's effectiveness in this setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stage IIIB or IV non-small cell lung cancer that is HER2-amplified or mutated.

Not a fit: Patients with early-stage non-small cell lung cancer or those who have previously received systemic anticancer therapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new first-line option for patients with advanced HER2-positive non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with HER2-targeted therapies in lung cancer, suggesting that this approach may be beneficial.

Eligibility criteria

Inclusion Criteria:

* 1\. Age: ≥18 years old; 2. Histologically confirmed stage IIIB or IV non-small cell lung cancer; 3. Have not previously received systemic anticancer therapy for stage IIIB or IV NSCLC; 4. HER2 insertion mutation, primary HER2 point mutation or primary HER2 amplification confirmed by genetic testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens; 5. There is at least one measurable lesion determined based on RECIST 1.1; 6. ECOG score 0-1 points; 7. Expected survival period ≥ 12 weeks; 8. Cardiac ultrasound examination showed that left ventricular ejection fraction (LVEF) ≥ 50%; 9. The patient's bone marrow function, liver and kidney function were confirmed to meet the following requirements by laboratory tests before the first administration:

  1. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
  2. Platelet count (PLT) ≥ 75,000/mm3 (75×109/L);
  3. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
  4. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min;
  5. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
  6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN.

     10\. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

     Exclusion Criteria:
* 1\. Previous use of EGFR TKI therapy; 2. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 3. Symptomatic brain metastases or meningeal metastases; 4. Insufficient bone marrow reserve or insufficient organ function; 5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow drugs, etc., may affect the intake, transport or absorption of drugs; 6. Received major surgical operation or severe traumatic injury, fracture, or poor healing wound within 4 weeks; 7. Known history of other malignancies, unless the subject has received potentially curative therapy prior to initiation of therapy and has at least 3 years of evidence of disease-free recurrence (non-small cell lung cancer, radical skin basal cell undergoing successful resection) carcinoma, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ or other carcinoma in situ); 8. Those who have serious adverse reactions and allergies to the drugs and excipients used in this group; 9. Pregnant or lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 10. The patient has serious concomitant diseases, or any other condition that the investigator considers the patient unsuitable to participate in this study.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Non-small Cell Lung Cancer