Actively Recruiting
Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
Led by Guangdong Association of Clinical Trials · Updated on 2020-07-23
60
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Local Therapy in Advanced NSCLC With Non-progressive Disease (PD) After First Line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 years or older, with life expectancy of at least 12 weeks.
- Histologically confirmed metastatic (stage IV) non-small cell lung cancer.
- Genetic testing completed for EGFR, ALK, and ROS1.
- Achieved complete response, partial response, or stable disease after front line systemic treatment.
- Total metastatic lesions limited to five or fewer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Measurable disease according to RECIST version 1.1.
- Adequate liver function: AST and ALT ≤ 2.5 times upper limit of normal (ULN) without liver metastases or ≤ 5 times ULN with liver metastases; total bilirubin ≤ 1.5 times ULN.
- Adequate bone marrow function: granulocyte count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 80 g/dL.
- Adequate renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function.
- Negative pregnancy test within 48 hours before enrollment for women of childbearing potential; postmenopausal women must have been amenorrhoeic for at least 12 months.
- Males must agree to use effective contraception during the study and for 12 weeks after treatment.
- Written informed consent.
- Willingness and ability to comply with scheduled visits, treatments, lab tests, and procedures.
You will not qualify if you...
- Patients with stage I-IIIa NSCLC who completed radical treatment and are undergoing systemic therapy after recurrence.
- Patients with progression-free survival less than or equal to 3 months on first-line therapy.
- History of other malignancies within 5 years, except treated carcinoma in situ of cervix or basal/squamous cell skin cancer.
- Prior palliative surgery or local therapy directed at advanced lung cancer.
- Contraindications to localized treatment such as surgery, radiotherapy, or interventional therapy.
- Unstable systemic diseases including active infections, significant cardiovascular, hepatic, renal, or metabolic diseases.
- Risk of transmitting HIV according to investigator.
- Nursing or lactating women.
- Sexually active males or females of childbearing potential unwilling to use contraception.
- Mental disorders or conditions affecting compliance.
- Unwillingness to provide informed consent.
- Unwillingness to accept follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong General Hospital
Guangzhou, Guagndong, China, 510080
Actively Recruiting
Research Team
Z
ZHEN WANG, PhD,MD
CONTACT
H
Hui-fen Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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