Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
Guangdong Association of Clinical Trials
60 participants
Jun 1, 2020
INTERVENTIONAL
Conditions
Summary
This is a prospective single arme real-world study clinical study, which aims to investigate the overall benefit and safety of consolidative therapy in advanced NSCLC (stage III/IV) patients , who do not progress after front line systemic therapy (chemotherapy, target therapy or immunological checkpoint inhibitors).
Eligibility
Inclusion Criteria15
- 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 Criteria12
- 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.
Interventions
local consolidative treatment to primary or metastases, which includes surgery, radiotherapy or interventional therapy
Locations(1)
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NCT03046316