NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer
M.D. Anderson Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 2. Age ≥ 18 years. 3. ECOG Performance Status 0-2 4. Biopsy proven stage I-III NSCLC. 5. Participant deemed medically inoperable by the investigator or treating physician, or patient declines surgery. 6. No prior or concurrent systemic therapies within 4 weeks of injection. Patient may receive up to 1 line of prior systemic therapy prior to starting RT. 7. Amenable to undergo bronchoscopic (EBUS, CB…
Interventions
- DrugNBTXR3
Given by injection
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas