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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT04797702
Eligibility Criteria:
Inclusion criteria:
1. Subsubjects with histologically or cytologically confirmed NSCLC, clinically diagnosed as locally advanced (stage IIIB or IIIC) and stage IV NSCLC (according to AJCC 8th edition staging), EGFR wild-type, negative for ALK and ROS1 rearrangement, and no Met exon14 skipping mutation; genetic testing is not mandatory for subjects with squamous cell cancer;
2. PD - L1 expression of 1% or higher.
3. Non-small cell lung cancer patients following failure of or were intolerance to previous standard treatment (chemotherapy and immunotherapy alone or in combination) and received no more than third-line treatment;
4. At least 1 measurable tumor lesion according to RECIST1.1 criteria.
5. Subjects must provide valid and qualified tissue samples (fresh biopsy or preserved tumor tissue samples are acceptable, but fresh biopsy samples are preferred).
6. ECOG score ≤1 point;
7. Sufficient function of bone marrow, liver and kidney organs.
Exclusion criteria:
1. Pathological diagnosis confirmed the presence of small cell lung cancer;
2. The patient was currently participating in and receiving other studies or had previously received another c-Met inhibitor;
3. There are mutations/rearrangements of EGFR, ALK, ROS1, Met14 exon skipping;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04797702
Study Brief:
Protocol Section:
NCT04797702