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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT04818333
Eligibility Criteria:
Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
4. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
5. There is at least one measurable lesion according to RECIST V1.1 criteria
Exclusion Criteria:
1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
2. Has received HER2 antibody drug conjugates,
3. Central nervous system metastasis or meningeal metastasis with clinical symptoms
4. Has active infection requiring systemic treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04818333
Study Brief:
Protocol Section:
NCT04818333