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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT06092268
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 75 years old (inclusive), Female or male
2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
5. ECOG performance score of 0-1;
6. Expected survival time ≥ 12 weeks;
7. Adequate bone marrow and organ function
8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Exclusion Criteria:
1. Subjects with active central nervous system (CNS) metastases.
2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
3. Subjects with uncontrolled tumor-related pain
4. Clinically uncontrollable third space fluid
5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
6. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
10. Serious cardiovascular disease
11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
12. Presence of severe infection within 4 weeks prior to first dose of study drug
13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
14. Arterial/venous thrombotic events within 3 months prior to the first study dose
15. History of immunodeficiency, including a positive HIV test
16. Presence of active hepatitis B or C;
17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
18. Known history of alcohol or drug dependence or addiction;
19. Persons with mental disorders or poor compliance;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06092268
Study Brief:
Protocol Section:
NCT06092268