Status:
UNKNOWN
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
Lead Sponsor:
Beijing Chest Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
HER2 Mutant Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
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 speci...
Eligibility Criteria
Inclusion
- 1\. Age: 18-70 years old;
- 2\. Advanced/metastatic non-small lung cancer (IV) confirmed by pathology with measurable lesions;
- 3\. HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;
- 4\. ECOG：0-1;
- 5\. At least one radiographically measurable lesion
- 6\. Expected survival period ≥ 3 months
- 7\. Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography
- 8\. 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：
- Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
- Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);
- Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
- Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min;
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- 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;
- International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
- Urine protein \<2+; if urine protein ≥2+, the 24-hour urine protein quantification shows that protein must be ≤1g;
- 9\. The medication regimen of the subjects during the clinical diagnosis and treatment was pyrotinib as a single drug
- 10\. Patients voluntarily entered the study and signed informed consent form (ICF)
Exclusion
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05411276
Start Date
June 30 2022
End Date
December 31 2024
Last Update
June 9 2022
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