NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Age ≥ 18 years.
ECOG Performance Status 0-2
Biopsy proven stage I-III NSCLC.
Disqualifiers
Unable to undergo NBTXR3 injection via bronchoscopic or CT-guided approach
Unable to undergo radiation therapy for any reason
Female patients who are pregnant or breastfeeding.
Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly.
Trial design
Design model
Single group
Treatments tested in this trial
NBTXR3
DrugGiven by injection
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Phase I/II: Treatment with NBTXR3 + Radiation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Nanobiotix
Collaborator
Source ClinicalTrials.gov