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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT06014450
Eligibility Criteria:
Inclusion Criteria:
* Patients with pathologically or cytologically confirmed NSCLC; patients with clinical stage IV and no brain metastases \[AJCC 8th edition\]; no previous treatment
* Age 18 \~ 80 years old, body condition score ECOG 0 \~ 2 or KPS≥70;
* No contraindications such as radiotherapy, EGFR-TKI, chemotherapy, or immunotherapy;
* IMRT is required for primary tumor radiotherapy. DT: 60-70Gy
* Metastases are treated with three-dimensional radiotherapy (IMRT/SRT/SBRT/VMAT, etc.) and large segmentation radiotherapy.
* The subject must have no major organ dysfunction or laboratory tests that meet the following requirements:
* Hematological tests such as liver and kidney function were in the normal range of laboratory standards;
* Cardiac function: electrocardiogram excluded organic arrhythmia;
* Pulmonary function test: FEV1\>50%, mild-moderate lung function limited.
* Signed informed consent before treatment (radiotherapy, chemotherapy, immunization, targeted drug therapy); The patient had good compliance with the treatment and follow-up received.
Exclusion Criteria:
* Patients with brain metastasis;
* Stage IV NSCLC patients with malignant pleural effusion, pericardial effusion and other serous effusion;
* Patients with extensive liver metastasis and intrapulmonary metastasis that have seriously affected liver and lung function;
* Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmia within the past 12 months; Have a clinically clear diagnosis of heart valve disease; The disease active phase of bacterial, fungal, or viral infection; Mental disorders; Severe impaired lung function;
* Pregnant or lactating patients;
* Patients with a history of active malignancy other than small cell lung cancer prior to enrollment; Non-melanoma skin basal cell carcinoma, in situ cervical cancer, cured early prostate cancer excepted;
* Patients with an allergy and known or suspected allergy to any investigational drug for which no alternative medicine is available;
* Patients with poor compliance;
* Researchers consider it inappropriate to participate in this experiment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06014450
Study Brief:
Protocol Section:
NCT06014450