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:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT07170995
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary participation and written informed consent.
2. 18-75 years old, no gender limitation.
3. Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
4. Confirmed tumor PD-L1 status prior to randomization.
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1
6. With a life expectancy ≥ 3 months.
7. At least one measurable lesion according to RECIST v1.1.
Exclusion Criteria:
1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
3. Previous or co-existing malignancies；
4. Have Active or prior documented autoimmune or inflammatory disorders;
5. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
6. Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07170995
Study Brief:
Protocol Section:
NCT07170995