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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies

  This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.

  Recruiting Phase 1/2 Daiichi Sankyo · Taichung · NCT07890714

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

  This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07837739

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.