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:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
NCT ID:
NCT03046316
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age \>= 18 years, with life expectancy of at least 12 weeks.
* Patients with histologically documented metastatic (stage IV) non-small cell lung cancer.
* Subjected to driving genes examination including EGFR, ALK and ROS1.
* Achieve complete response (CR)/partial response (PR)/stable disease (SD) after front line systemic treatment (chemotherapy, targeted therapy or immunological checkpoint inhibitors).
* Total metastatic lesions is limited to five.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of \<= 2.
* Patients must have measurable disease according to the RECIST (version 1.1) criteria.
* Adequate organ function as defined by the following criteria:
* Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 2.5 upper limit of normal (ULN) in the absence of liver metastases or up to 5 ULN in case of liver metastases. Total bilirubin \<= 1.5 ULN.
* Bone marrow function: Granulocyte count \>= 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin \>= 80g/dl.
* Renal function: serum creatinine \<= 1.5 ULN or creatinine clearance \>= 60 ml/min. (based on modified Cockcroft-Gault formula).
* Adequate coagulating function.
* For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Males must agree to use effective contraception during the study period and for at least 12 weeks after completion of the study treatment.
* Written (signed) informed Consent to participate in the study.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* Stage I-III a NSCLC completing radical treatment , then undergoing systemic anti-cancer treatment after recurrence.
* Patients with PFS no more than 3 months. to first line theray.
* Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
* Prior palliative surgery or other local therapy specifically directed against advanced lung cancer.
* Contraindication for localized treatment including surgery, radiotherapy or interventional therapy judged by physicians.
* Patients with any unstable systemic disease (including active infections, significant cardiovascular disease, any significant hepatic, renal or metabolic disease).
* Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
* Nursing or lactating women.
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
* Patients who has mental disorder or other disease that contribute to no compliance.
* Unwilling to write informed consent to participate in the study.
* Patients who is unwilling to accept the follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03046316
Study Brief:
Protocol Section:
NCT03046316