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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05636267
Eligibility Criteria:
Inclusion Criteria:
1. Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure.
2. Age ≥ 18 and ≤ 75, male or female.
3. Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer.
4. EGFR activating mutation confirmed by tumor histology, cytology or hematology.
5. Failed to previous EGFR-TKI treatment.
6. ECOG performance status 0 to1.
7. Life expectancy ≥3 months.
8. At least one measurable lesion according to RECIST v1.1.
9. Adequate organ function.
Exclusion Criteria:
1. Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma.
2. Have suffered from the second primary active malignant tumor in the past 3 years.
3. There are other driving gene mutations that can obtain effective treatment.
4. Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks.
5. Symptomatic central nervous system metastases.
6. The toxicity of previous anti-tumor therapy has not been alleviated.
7. Uncontrolled massive ascites, pleural effusion or pericardial effusion.
8. Active autoimmune diseases in the past 2 years.
9. History of interstitial lung disease or noninfectious pneumonitis.
10. Suffering from clinically significant cardiovascular or cerebrovascular diseases.
11. History of severe bleeding tendency or coagulation dysfunction.
12. History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months.
13. Serious infection in the past 4 weeks.
14. Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks.
15. History of human immunodeficiency virus (HIV) infection.
16. History of severe hypersensitivity reactions to other mAbs.
17. History of organ transplantation.
18. Any other conditions that, in the opinion of the investigator, may increase the risk when receiving the investigational product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05636267
Study Brief:
Protocol Section:
NCT05636267