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Site for A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer (22-026) (A082002)
To assess if SBRT improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage NSCLC patients with PD-L1 TPS <1% who receive immunotherapy with or without chemotherapy
We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
All
18 year(s) or older
NCT04929041
SITE00001209
Inclusion Criteria:
Age ≥ 18 yearsNo prior systemic chemotherapy or immunotherapy for advanced NSCLC
Not pregnant and not nursing
No known history of Hepatitis B or Hepatitis C
Platelet Count ≥ 100,000/mm3
Exclusion Criteria:
Live vaccine within 30 days prior to registrationCurrent pneumonitis or history of non-infectious pneumonitis that required steroids
Prior allogeneic tissue/solid organ transplant.
Age < 18 years
ECOG Performance Status over 3
Cancer
Not applicable