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 @ 3:05 AM
Ignite Modification Date:
2025-12-25 @ 3:05 AM
NCT ID:
NCT06208033
Eligibility Criteria:
Inclusion Criteria:
* 1\. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures.
2\. Age ≥ 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry ≥ \[+\]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period \> 3 months).
4\. At least one measurable lesion via RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Expected survival ≥ 3 months. 7. Adequate organ function .
Exclusion Criteria:
* 1\. Driver gene-positive (EGFR, ALK, ROS1) . 2. history of dual primary malignancies within the past 5 years. 3. active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy.
4\. systemic infections requiring systemic treatment. 5. known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator.
6\. Fertile individuals unable to maintain effective contraception during the trial.
7\. Subjects in Cohort B who have received prior docetaxel treatment. 8. Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors.
9\. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06208033
Study Brief:
Protocol Section:
NCT06208033