Clinical trial NCT03046316: Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
Official title: Local Consolidative Therapy (LCT) in Patients With Advanced Stage Non-small Cell Lung Cancer Who do Not Progress After Front Line Systemic Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasms
Keywords: Therapeutics
local therapy
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: It is required that pathological diagnosis and genetic profile including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) be established prior to enrollment. Standard front line systemic should be given according to clinical practice. Molecular targeting drugs for patients with driving mutations should be acquired legally. Patients without driving mutations should undergo standard first line chemotherapy and or immunological checkpoint inhibitors. One cycle is three weeks and response evaluation is done every two cycles. CR, PR and SD should be confirmed after four cycles of therapy.

Patients, who achieve non-PD after four cycles of treatment, with distant metastasis involving no more than five total metastatic lesions, will be screened and enrolled.

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.

Primary outcomes:
measure: Progression free survival
timeFrame: 8 months
Secondary outcomes:
measure: Response rate
timeFrame: 6 months
measure: Lung Cancer Symptom Scale
timeFrame: 12 months
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guagndong
Study officials:
affiliation: Guangdong General Hospital&Guangdong Academy of Medical Sciences
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
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