Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT04675060
Eligibility Criteria:
Inclusion Criteria:
* 1\. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
2\. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
4\. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
6.Understood and signed an informed consent form.
Exclusion Criteria:
* 1\. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
4\. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
5\. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.
9\. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.
12\. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
13\. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.
14\. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04675060
Study Brief:
Protocol Section:
NCT04675060