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Trial Title:
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
NCT ID:
NCT05751018
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly
inhibit HER1, HER2, and HER4.
Arm group label:
pyrotinib
Summary:
This is a multicenter, single-arm phase II clinical study to evaluate the safety and
efficacy of pyrotinib maleate as a first-line treatment for HER2-mutated or amplified
non-small cell lung cancer. Pyrotinib maleate is a small molecule tyrosine kinase
inhibitor that can irreversibly inhibit HER1, HER2, and HER4.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age: ≥18 years old; 2. Histologically confirmed stage IIIB or IV non-small cell
lung cancer; 3. Have not previously received systemic anticancer therapy for
stage IIIB or IV NSCLC; 4. HER2 insertion mutation, primary HER2 point mutation
or primary HER2 amplification confirmed by genetic testing of tumor tissue or
blood, pleural effusion, cerebrospinal fluid and other specimens; 5. There is
at least one measurable lesion determined based on RECIST 1.1; 6. ECOG score
0-1 points; 7. Expected survival period ≥ 12 weeks; 8. Cardiac ultrasound
examination showed that left ventricular ejection fraction (LVEF) ≥ 50%; 9. The
patient's bone marrow function, liver and kidney function were confirmed to
meet the following requirements by laboratory tests before the first
administration:
1. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
2. Platelet count (PLT) ≥ 75,000/mm3 (75×109/L);
3. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
4. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or
creatinine clearance ≥ 60 mL/min;
5. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5
times the upper limit of normal (ULN), patients with liver metastases should be
≤ 5×ULN.
10. The subjects voluntarily joined the study, signed the informed consent
form, had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
-
1. Previous use of EGFR TKI therapy; 2. Participated in clinical trials of other
drugs within 4 weeks before the start of the study; 3. Symptomatic brain
metastases or meningeal metastases; 4. Insufficient bone marrow reserve or
insufficient organ function; 5. Refractory nausea and vomiting, chronic
gastrointestinal diseases, inability to swallow drugs, etc., may affect the
intake, transport or absorption of drugs; 6. Received major surgical operation
or severe traumatic injury, fracture, or poor healing wound within 4 weeks; 7.
Known history of other malignancies, unless the subject has received
potentially curative therapy prior to initiation of therapy and has at least 3
years of evidence of disease-free recurrence (non-small cell lung cancer,
radical skin basal cell undergoing successful resection) carcinoma, superficial
bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ
or other carcinoma in situ); 8. Those who have serious adverse reactions and
allergies to the drugs and excipients used in this group; 9. Pregnant or
lactating female patients, female patients with fertility and positive baseline
pregnancy test, or patients of childbearing age who are unwilling to take
effective contraceptive measures throughout the trial; 10. The patient has
serious concomitant diseases, or any other condition that the investigator
considers the patient unsuitable to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhang NA Li, Doctor of Medicine；
Phone:
13911339836
Email:
pumchzhangli@163.com
Contact backup:
Last name:
Si Xiao Yan, Doctor of Medicine；
Phone:
13718279816
Email:
xiaoyanfff@sina.com
Start date:
December 8, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751018
