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 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07482605
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years but ≤ 75 years;
2. Histologically or cytologically confirmed advanced lung adenocarcinoma;
3. Chest CT or whole-body PET-CT indicates pleural invasion with pleural effusion, and pleural fluid cytology confirms the presence of cancer cells. After 2 months of treatment with furmonertinib ± thoracentesis drainage, malignant pleural effusion is controlled (no pleural effusion or only ≤ 100 ml of pleural effusion), and a small amount of pericardial effusion may be present;
4. No prior history of thoracic radiotherapy or thoracic surgery;
5. Positive for EGFR-sensitive mutations (19del/L858R);
6. No prior systemic anti-tumor therapy;
7. ECOG performance status 0-1, with a life expectancy of ≥ 12 weeks;
8. At least one measurable lesion (according to RECIST 1.1);
9. Signed informed consent obtained;
10. No more than 3 bone metastases.
Exclusion Criteria:
1. Complicated with interstitial pneumonia or infectious fever before treatment;
2. Complicated with autoimmune diseases or long-term oral corticosteroid use;
3. Prior history of thoracic radiotherapy or thoracic surgery;
4. Complicated with severe anemia, grade 3 WBC or PLT suppression;
5. Allergic to third-generation TKIs;
6. Obvious respiratory symptoms, intolerant to radiotherapy;
7. Active hepatitis B or hepatitis C infection, or currently undergoing antiviral treatment; patients with a clear history of HBV infection whose HBV DNA is at an undetectable level after previous active treatment may be enrolled;
8. Poor control or continuous progression of pleural effusion after two consecutive months of TKI treatment;
9. Patients with brain metastases or liver metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07482605
Study Brief:
Protocol Section:
NCT07482605