A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05411276
- Lead Sponsor
- Beijing Chest Hospital
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
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- Age: 18-70 years old;
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- Advanced/metastatic non-small lung cancer (IV) confirmed by pathology with measurable lesions;
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- HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;
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- ECOG：0-1;
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- At least one radiographically measurable lesion
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- Expected survival period ≥ 3 months
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- Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography
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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：
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Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
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Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);
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Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
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Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min;
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Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
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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;
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International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
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Urine protein <2+; if urine protein ≥2+, the 24-hour urine protein quantification shows that protein must be ≤1g;
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- The medication regimen of the subjects during the clinical diagnosis and treatment was pyrotinib as a single drug
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- Patients voluntarily entered the study and signed informed consent form (ICF)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Pyrotinib maleate HER2 rare mutation advanced/metastatic non-small lung cancer (IV)
- Primary Outcome Measures
Name Time Method ORR 2 Year It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
- Secondary Outcome Measures
Name Time Method QoL 1 Year The quality of life of the subjects was assessed according to the EORTC QLQ-C30 quality of life questionnaire.
PFS 1 Year From the date Into this study to tumor progression or death for any
AEs and SAEs 1 Year Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
OS 2 Year The time from the beginning of treatment to the death of the subject due to various reasons, calculated by the intended treatment population (ITT)
DCR 2 Year the rate of CR, PR plus SD