NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 34
Summary
- Conditions
- Stage IA3 Lung Cancer AJCC v8
- Recurrent Lung Non-Small Cell Carcinoma
- Stage I Lung Cancer AJCC v8
- Stage IA1 Lung Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Unresectable Lung Non-Small Cell Carcinoma
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiotherapy in patients with inoperable, locoregional recurrent non-small cell lung cancer (NSCLC), previously treated with definitive radiation therapy. SE...
PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiotherapy in patients with inoperable, locoregional recurrent non-small cell lung cancer (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.
Tracking Information
- NCT #
- NCT04505267
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Saumil Gandhi M.D. Anderson Cancer Center
Get Well Soon