HER2 Mutant Non-small Cell Lung CancerNCT05411276
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
An observational study of HER2 Mutant Non-small Cell Lung Cancer, run by Beijing Chest Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HER2 Mutant Non-small Cell Lung Cancer
- What is being tested?
- Pyrotinib maleate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HER2 rare mutation advanced/metastatic non-small lung cancer (IV)
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.;
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- 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 locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Pyrotinib maleate
- Keywords
- Non-Small Cell Lung Cancer, Rare Mutation of HER2, Pyrotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib maleateDrug
Pyrotinib maleate tablets 400 mg/day, oral within 30 minutes after breakfast, every 4 weeks is a cycle
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | HER2 rare mutation advanced/metastatic non-small lung cancer (IV) Receives: Drug: Pyrotinib maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Year
Secondary outcomes (5)
PFS
From the date Into this study to tumor progression or death for any
Measured: 1 Year
OS
The time from the beginning of treatment to the death of the subject due to various reasons, calculated by the intended treatment population (ITT)
Measured: 2 Year
DCR
the rate of CR, PR plus SD
Measured: 2 Year
AEs and SAEs
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.
Measured: 1 Year
QoL
The quality of life of the subjects was assessed according to the EORTC QLQ-C30 quality of life questionnaire.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Mutant Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Ying Hu, Beijing Chest Hospital
- Investigators
- Ying Hu, Doctor, Principal investigator, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411276
- Sponsor's protocol ID
- KY-2021-012
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
- ClinicalTrials.gov ID
- NCT05411276
- Acronym / sponsor ID
- KY-2021-012
- Conditions
- HER2 Mutant Non-small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Rare Mutation of HER2, Pyrotinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Pyrotinib maleateHER2 rare mutation advanced/metastatic non-small lung cancer (IV) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER2 rare mutation advanced/metastatic non-small lung cancer (IV)
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyrotinib maleatePyrotinib maleate tablets 400 mg/day, oral within 30 minutes after breakfast, every 4 weeks is a cycle | Drug | Group 1 |
Primary outcome
ORR
Time frame: 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.
5 secondary outcomes
PFS
Time frame: 1 Year
OS
Time frame: 2 Year
DCR
Time frame: 2 Year
AEs and SAEs
Time frame: 1 Year
QoL
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Hu, Doctor principal investigator
Beijing Chest Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 Mutant Non-small Cell Lung Cancer, run by Beijing Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Hu, Doctor (010-89509304, huying@bjxkyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.