Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial

Arta M. Monjazeb, Megan E. Daly (), Guillaume Luxardi, Emanual Maverakis, Alexander A. Merleev, Alina I. Marusina, Alexander Borowsky, Amin Mirhadi, Stephen L. Shiao, Laurel Beckett, Shuai Chen, David Eastham, Tianhong Li, Logan V. Vick, Heather M. McGee, Frances Lara, Leslie Garcia, Leigh Anne Morris, Robert J. Canter, Jonathan W. Riess, Kurt A. Schalper, William J. Murphy and Karen Kelly
Additional contact information
Arta M. Monjazeb: UC Davis Health
Megan E. Daly: UC Davis Health
Guillaume Luxardi: UC Davis Health
Emanual Maverakis: UC Davis Health
Alexander A. Merleev: UC Davis Health
Alina I. Marusina: UC Davis Health
Alexander Borowsky: UC Davis Health
Amin Mirhadi: Cedars-Sinai Medical Center
Stephen L. Shiao: Cedars-Sinai Medical Center
Laurel Beckett: UC Davis Health
Shuai Chen: UC Davis Health
David Eastham: David Grant USAF Medical Center, Travis AFB
Tianhong Li: UC Davis Health
Logan V. Vick: UC Davis Health
Heather M. McGee: City of Hope Cancer Center
Frances Lara: UC Davis Health
Leslie Garcia: UC Davis Health
Leigh Anne Morris: UC Davis Health
Robert J. Canter: UC Davis Health
Jonathan W. Riess: UC Davis Health
Kurt A. Schalper: Yale School of Medicine
William J. Murphy: UC Davis Health
Karen Kelly: UC Davis Health

Nature Communications, 2023, vol. 14, issue 1, 1-14

Abstract: Abstract 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.

Date: 2023
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DOI: 10.1038/s41467-023-40813-w

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