Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy

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 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.

Conditions3

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