NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer
brief summary
This is a single institution, single arm phase I/II study of NBTXR3 with radiation therapy for stage I-III advanced non-small cell lung cancer patients who are not candidates for chemotherapy or surgical resection.
detailed description
Primary Objectives:
Phase I
To evaluate the feasibility and safety of radiation therapy with NBTXR3 in LA-NSCLC with the following dose escalation:
* 45 Gy in 15 fx with NBTXR3 at 22% RP2D * 52.5 Gy in 15 fx with NBTXR3 at 22% RP2D * 60 Gy in 15 fx with NBTXR3 at 22% RP2D * 60 Gy in 15 fx with NBTXR3 at 33% RP2D
Phase II
* To estimate the efficacy of radiation therapy alone with NBTXR3 in inoperable, locoregional NSCLC * To evaluate the safety of RP2D
Secondary Objectives:
* To evaluate the anti-tumor response of radiation with NBTXR3 in patients with inoperable, locoregional NSCLC * To evaluate time-to-event outcomes for radiation therapy with NBTXR3 in patients with inoperable, locoregional NSCL