NCT07224152

NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Locally-Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	NBTXR3	Given by injection

Timeline

• Start date: 2026-03-27
• Primary completion: 2028-08-30
• Completion: 2030-08-30
• First posted: 2025-11-04
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study