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

NCT05411276 | Unknown

• 1 other identifier: KY-2021-012
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HER2 Mutant Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Rare Mutation of HER2; Pyrotinib

Outcome Measures

Primary Outcomes (1)

• ORR

  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.

  2 Year

Secondary Outcomes (5)

• PFS

  1 Year

• OS

  2 Year

• DCR

  2 Year

• AEs and SAEs

  1 Year

• QoL

  1 Year

Study Arms (1)

Group 1

HER2 rare mutation advanced/metastatic non-small lung cancer (IV)

Drug: Pyrotinib maleate

Interventions

Pyrotinib maleate DRUG

Pyrotinib maleate tablets 400 mg/day, oral within 30 minutes after breakfast, every 4 weeks is a cycle

Group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2 rare mutation advanced/metastatic non-small lung cancer (IV)

You may qualify if:

• \. Age: 18-70 years old;
• \. Advanced/metastatic non-small lung cancer (IV) confirmed by pathology with measurable lesions;
• \. HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;
• \. ECOG：0-1;
• \. At least one radiographically measurable lesion
• \. Expected survival period ≥ 3 months
• \. Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography
• \. 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chest Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ying Hu, Doctor

  Beijing Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Hu, Doctor

CONTACT

010-89509304; huying@bjxkyy.cn

Xinyong Zhang, Master

CONTACT

010-89509324; dkf36@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Second Department of Oncology

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-06