Durvalumab is a drug that stimulates the immune system to fight lung cancer. Durvalumab is FDA approved to treat lung cancer. Stereotactic body radiation therapy (SBRT) is a newer radiation treatment that gives fewer, but higher doses of radiation than standard radiation. With SBRT, radiation is focused toward the cancer and away from normal surrounding lung tissue. It is possible that when cancer cells are damaged by SBRT Durvalumab may be more effective in activating the immune system. SBRT is a standard FDA approved treatment for early stage (stage 1) lung cancer and is investigational in patients such as yourself with stage 3 lung cancer. The combination of Durvalumab and SBRT is investigational. This study will investigate the effects, good and bad, of the combination of Durvalumab and SBRT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Durvalumab10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)
SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab. The dose will consist of 20Gy (2 fractions of 10Gy) \*3 fractions are allowed for centrally located tumors
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Number of patients experiencing grade 2 or higher toxicities during consolidation SBRT with concurrent durvalumab after chemoradiation for locally advanced stage III NSCLC
This outcome will examine the safety and tolerability of the trial.
Time frame: Defined as the first 3 months of durvalumab.
Average progression-free survival of chemoradiation followed by SBRT and durvalumab for patients with locally advanced stage III NSCLC.
RECIST 1.1
Time frame: Every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 years.
Overall survival (OS)
Time frame: Every 2 months for the first 6 months, then every 4 months for 2 years then every 6 months for 2 years then yearly for about 5 years
Average time to local-regional progression (LRP)
Time frame: Every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression for about 5 years.
Time to distant metastasis (DM)
Time frame: Every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.