A Phase I Trial of an Immune Checkpoint Inhibitor Plus Stereotactic Ablative Radiotherapy in Patients with Inoperable Stage I Non-Small Cell Lung Cancer
Technical Report,30 Sep 2015,29 Sep 2016
University of California, Davis Davis United States
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This clinical trial is the first to evaluate the synergy between radiation, a well-known immune modulator, with the novel immune checkpoint inhibitor MPDL3280A atezolizumab in early stage inoperable non-small cell lung cancer. The trial is comprised of a traditional 3 3 phase I design followed by a dose expansion. We have enrolled 3 patients into dose level 1. Two patients have completed the entire treatment plan and 1 patient is in the 9-week dose limiting time period. The regimen has been well tolerated with no dose limiting toxicities observed in the first two patients. One patient had a partial response and the other patient has stable disease. Interestingly patient 1 had tumor shrinkage after two cycles of low dose MPDL3280A without the radiation. The trial continues as planned.
- Medicine and Medical Research