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Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial
- Monjazeb, Arta M;
- Daly, Megan E;
- Luxardi, Guillaume;
- Maverakis, Emanual;
- Merleev, Alexander A;
- Marusina, Alina I;
- Borowsky, Alexander;
- Mirhadi, Amin;
- Shiao, Stephen L;
- Beckett, Laurel;
- Chen, Shuai;
- Eastham, David;
- Li, Tianhong;
- Vick, Logan V;
- McGee, Heather M;
- Lara, Frances;
- Garcia, Leslie;
- Morris, Leigh Anne;
- Canter, Robert J;
- Riess, Jonathan W;
- Schalper, Kurt A;
- Murphy, William J;
- Kelly, Karen
- et al.
Published Web Location
https://doi.org/10.1038/s41467-023-40813-wAbstract
Stereotactic ablative radiotherapy (SABR) is a standard-of-care for medically-inoperable-early-stage non-small cell lung cancer (NSCLC). One third of patients progress and chemotherapy is rarely used in this population. We questioned if addition of the immune-checkpoint-inhibitor (ICI) atezolizumab to standard-of-care SABR can improve outcomes. We initiated a multi-institutional single-arm phase I study (NCT02599454) enrolling twenty patients with the primary endpoint of maximum tolerated dose (MTD); secondary endpoints of safety and efficacy; and exploratory mechanistic correlatives. Treatment is well tolerated and full dose atezolizumab (1200 mg) is the MTD. Efficacy signals include early responses (after 2 cycles of ICI, before initiation of SABR) in 17% of patients. Biomarkers of functional adaptive immunity, including T cell activation in the tumor and response to ex-vivo stimulation by circulating T cells, are highly predictive of benefit. These results require validation and are being tested in a phase III randomized trial.
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