Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT04505267
Brief Summary:
This phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiotherapy energy dose deposition inside tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NBTXR3 and radiation therapy may increase radiation-dependent tumor cell killing without increasing the radiation exposure of healthy surrounding tissues.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the safety of 45 Gy in 15 fractions in patients with inoperable, locoregional recurrent NSCLC, previously treated with definitive radiation therapy.
II. To determine the recommended phase II dose (RP2D) of NBTXR3 activated by radiotherapy in patients with inoperable, locoregional recurrent NSCLC, previously treated with definitive radiation therapy.
SECONDARY OBJECTIVES:
I. To evaluate the safety and feasibility of reirradiation with NBTXR3 in patients with inoperable, locoregionally recurrent NSCLC.
II. To evaluate the anti-tumor response of reirradiation with NBTXR3 in patients with inoperable, locoregionally recurrent NSCLC.
III. To evaluate time-to-event outcomes after reirradiation with NBTXR3 in patients with inoperable, locoregionally recurrent NSCLC
EXPLORATORY OBJECTIVE:
I. To assess biomarkers of response in patients treated with NBTXR3/radiation therapy (RT).
OUTLINE: This is a dose-escalation and dose-expansion study of NBTXR3.
Patients receive NBTXR3 intratumorally (IT) or intranodally on day 1. Within 15 days, patients undergo RT 5 times weekly (Monday-Friday) over 3 weeks for a total of 10-15 fractions.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for up to 5 years.
Study:
NCT04505267
Study Brief:
Protocol Section:
NCT04505267