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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07489703
Eligibility Criteria:
Inclusion Criteria:
1. Signed ICF.
2. Age 18-75.
3. ECOG PS 0-1.
4. Life expectancy ≥3 months.
5. Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.
6. Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .
7. ≥1 measurable lesion per RECIST 1.1.
8. Adequate organ and bone marrow function.
9. Use of effective contraception.
Exclusion Criteria:
1. History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
2. Arterial/venous thrombotic event within 6 months.
3. Significant cardiovascular disease.
4. Active autoimmune disease requiring systemic treatment.
5. Use of systemic immunosuppressants within 2 weeks prior.
6. Symptomatic pleural/pericardial/ascitic effusion requiring drainage.
7. Symptomatic, progressive, or diffusely spread CNS metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07489703
Study Brief:
Protocol Section:
NCT07489703