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

NCT05411276•Beijing Chest Hospital

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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：
•1. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
•2. Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);
+8 more criteria

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;
+4 more criteria

Key Dates

Start Date

June 30, 2022

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

June 9, 2022

Enrollment

ESTIMATED participants

Conditions

HER2 Mutant Non-small Cell Lung Cancer

Interventions

Pyrotinib maleate

DRUG

Contacts

Ying Hu, Doctor

CONTACT

010-89509304 huying@bjxkyy.cn

Xinyong Zhang, Master

CONTACT

010-89509324 dkf36@163.com