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Lung cancer is one of the malignant tumors that seriously threaten human health, mortality and incidence rank first in the country's malignant tumors, with the continuous deepening of people's understanding of the occurrence and development of lung cancer, pay close attention to various comprehensive treatment methods, the clinical treatment effect of lung cancer has been significantly improved compared with the past. The peritinib developed by Beijing Purunao Biotechnology Co., Ltd. has been approved by the State Food and Drug Administration, and the clinical batch number (CTR20160228) has been carried out in clinical trials for the treatment of non-small cell lung cancer.
The full name of this experiment is "a phase I, open, multicenter, dose-increasing and extended study to investigate the tolerability and pharmacokinetics of britinib in NSCLC patients with abnormal c-Met", and the lead unit of the project is Guangdong Provincial People's Hospital, and subjects are now openly recruited.
【Test drug】Peritinib
【Indications】Non-small cell lung cancer
【Purpose of the test】
To assess the tolerability of brititinib with single and multiple oral administrations in patients with advanced NSCLC with c-Met abnormalities, to determine the recommended doses of DLT, MTD, and phase II (RP2D).
【Main Selection Criteria】
1. Sign written informed consent to participate in the study.
2. Male or female aged 18 years or older.
3. Patients with advanced non-small cell lung cancer confirmed by histology.
4. The laboratory test of the research center confirms the existence of c-Met abnormalities.
5. At least one measurable lesion (according to THE RECIST1.1 standard).
6. No systematic anti-tumor chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy has been performed in the past 4 weeks (targeted therapy is completed 2 weeks before the selection); the study treatment must have been restored to the level of Class I from the adverse reactions of previous treatment before the start of the study treatment.
7. Expected survival ≥ 3 months.
【Main Exclusion Conditions】
1. Reluctance to provide blood or tumor tissue samples for molecular screening.
2. Previously received c-Met inhibitors or HGF targeted therapy.
3. Development of symptomatic and neurologically unstable central nervous system CNS metastases, or the need to increase steroid doses to control CNS disease.
4. Unstable or uncontrollable disease or conditions related to or affecting cardiac function (e.g., unstable angina, congestive heart failure [NYHA > grade II], uncontrolled hypertension [diastolic > 85 mmHg; systolic blood pressure > 145 mmHg]) or arrhythmias.
5. Study the history of arterial thromboembolism (eg, stroke, transient ischemic attack, or myocardial infarction) in the 6 months before day 1. There was bleeding or hypercoagulable coagulation disorders within 6 months prior to day 1 of the study.
【Location of the main research center (the specific start-up situation is subject to the later consultation)】
Guangdong, Hunan, Guangxi, Beijing, Fujian, Hubei, Jiangsu, Zhejiang, Shanghai, Shandong, Henan, Sichuan, Jilin, Shaanxi
Participating in clinical trials can receive free treatment for new therapies, and patients interested in participating in this clinical trial can consult a medical companion.
Note: Whether you can finally join the group needs to be determined by the doctor.
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