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A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2

B

Beijing Chest Hospital

Status

Not yet enrolling

Conditions

HER2 Mutant Non-small Cell Lung Cancer

Treatments

Drug: Pyrotinib maleate

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05411276
KY-2021-012

Details and patient eligibility

About

At present, the main characteristics of the enrolled population in the clinical study of HER2-mutated non-small cell lung cancer are the YVMA mutation type. There are no relevant clinical trials specifically targeting rare mutation types. Pyrotinib has been approved for the treatment of HER2-positive advanced breast cancer in China, and pyrotinib has shown good development prospects in the treatment of advanced non-small cell lung cancer. The purpose of this study is to observe the efficacy and safety of pyrotinib maleate in patients with HER2 rare mutation in advanced non-small cell lung cancer.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Age: 18-70 years old;
    1. Advanced/metastatic non-small lung cancer (IV) confirmed by pathology with measurable lesions;
    1. HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;
    1. ECOG:0-1;
    1. At least one radiographically measurable lesion
    1. Expected survival period ≥ 3 months
    1. Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography
    1. Before using the drug for the first time, it was confirmed by laboratory tests that the subject's bone marrow function, liver and kidney function met the following requirements:

    2. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);

    3. Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);

    4. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);

    5. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min;

    6. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);

    7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN), and subjects with liver metastases should be ≤ 5×ULN;

    8. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;

    9. Urine protein <2+; if urine protein ≥2+, the 24-hour urine protein quantification shows that protein must be ≤1g;

    1. The medication regimen of the subjects during the clinical diagnosis and treatment was pyrotinib as a single drug
    1. Patients voluntarily entered the study and signed informed consent form (ICF)

Exclusion criteria

  • Common types of HER2 mutations: YVMA mutations;
  • Patients with hypertension that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); Uncontrolled or severe cardiovascular disease, such as refractory angina pectoris, congestive heart failure occurred within 6 months before screening; Myocardial infarction within 12 months prior to screening; Any history of clinically significant ventricular arrhythmia, prolonged QT interval; History of cerebrovascular accident, symptomatic coronary heart disease requiring drug treatment;
  • There are significant digestive tract dysfunction, which may affect the intake, transport or absorption of oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  • Subjects with a recent history of active bleeding, clinically significant bleeding symptoms, and a clear bleeding tendency, such as hemoptysis, gastrointestinal bleeding, hemorrhagic gastric ulcer, positive fecal occult blood at baseline and above, etc.;
  • Major surgical operations or severe traumatic injuries, fractures, or poorly healing wounds have been received within 4 weeks;
  • Uncontrollable history of important respiratory system such as bronchiectasis, chronic obstructive pulmonary disease, lung abscess, pulmonary embolism, etc.;
  • Active serious clinical infection (>NCI-CTCAE, 5.0 version 2 infection standard) and viral infections such as hepatitis B, hepatitis C, syphilis and HIV;
  • Symptomatic brain metastases or meningeal metastases;
  • Combined with previously untreated tumors other than primary lung cancer;
  • Participated in clinical trials of other drugs within 4 weeks before the start of the study;
  • Received treatment with pyrotinib maleate;
  • Those who have serious adverse reactions and allergies to pyrotinib maleate;
  • Pregnant or lactating female subjects, female subjects who are fertile and have a positive baseline pregnancy test, or subjects of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
  • Have serious concomitant diseases, or any other conditions that the investigator considers unsuitable to participate in this study.

Trial design

15 participants in 1 patient group

Group 1
Description:
HER2 rare mutation advanced/metastatic non-small lung cancer (IV)
Treatment:
Drug: Pyrotinib maleate

Trial contacts and locations

0

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Central trial contact

Xinyong Zhang, Master; Ying Hu, Doctor

Data sourced from clinicaltrials.gov

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