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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT04992858
Eligibility Criteria:
Inclusion Criteria:
* Age:18-75 years, male or female.
* Histologically or cytologically confirmed IIIB-IV- Advanced NSCLC
* There was a Metex 14 skipping mutation in plasma and / or tissue
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 \~2
* Life expectancy of greater than 12 weeks.
* Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Adequate organ function.
* Contraception, fertility and not lactating female subjects: screening blood pregnancy test must be negative
* Voluntarily join the study and sign informed consent ad has good compliance.
Exclusion Criteria:
* EGFR or ALK or ROS1 gene mutation was positive
* Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;other anti-tumor therapies within 4 weeks, Previously or currently participating in other clinical trials within 4 week, Prior therapies with c-MET targeted drugs; Had received vaccine within 4 weeks prior to study treatment or had a plan to receive vaccine during the trial.
* Not recovered from adverse events due to a previously administered agent.
* Symptomatic, untreated or unstable central nervous system metastases/ spinal cord compression, cancerous meningitis, or meningitis.
* Patients with other malignant tumors except NSCLC within 5 years before the first use of drugs do not include those with negligible risk of metastasis or death (such as expected 5-year OS \> 90%) and expected to be cured after treatment, or any other tumors that have been cured (no evidence of recurrence within 5 years)
* There are prescribed cardiovascular and cerebrovascular risk factors
* Patients with evidence of bleeding tendency, or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
* History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs.
* There are uncontrollable and active infections
* Uncontrollable massive pleural / ascites or pericardial effusion
* Clinically significant gastrointestinal abnormalities may affect the drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy subjects;
* a history of psychotropic drug abuse and can not quit or have mental disorders
* Any other reason the investigator considers the patient is not suitable to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04992858
Study Brief:
Protocol Section:
NCT04992858