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NBTXR3 + Radiation Therapy for Lung Cancer

Phase 1

Recruiting

Led By Saumil Gandhi

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiation treatment received more than 6 months prior to enrollment.

ECOG Performance Status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from nbtxr3 injection to the radiographic confirmation (recist v1.1 and irrecist) of a new lesion outside the lungs and regional nodes or death from any cause, assessed up to 5 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines a new drug with radiation therapy. The goal is to see if the new treatment is more effective at killing cancer cells than radiation therapy alone.

Who is the study for?

This trial is for adults with inoperable, recurrent non-small cell lung cancer who've had radiation therapy over 6 months ago. They must be able to undergo a specific type of injection and have up to 4 treatable lung lesions. Participants need proper organ function and performance status (ECOG 0-2), may have limited additional cancer lesions, and must not be on other systemic cancer therapies or part of another clinical trial.Check my eligibility

What is being tested?

The study tests the optimal dose and side effects of NBTXR3 nanoparticles when used with radiation therapy. NBTXR3 aims to enhance the effect of radiotherapy on tumor cells without increasing damage to healthy tissue. The goal is more effective tumor shrinkage while sparing surrounding areas.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site, increased risk from radiation exposure such as skin changes or fatigue, possible inflammation around treated areas, and general discomfort associated with receiving injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My last radiation treatment was over 6 months ago.

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I can take care of myself and am up and about more than half of the day.

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My doctor says I cannot have surgery for my condition.

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My lab results are good enough for radiation therapy, as confirmed by my doctor.

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My lung cancer has returned in the same area after radiation, and it will be confirmed before treatment.

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My cancer can be measured on scans and any lymph node cancer is at least 15 mm across.

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At the time of screening, your blood test results need to show certain values within a specific range, and you need to meet other medical criteria. Also, you need to understand and agree to be part of the study.

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I am willing to have a special injection guided by a lung scan or bronchoscopy.

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I can have up to 4 lung lesions treated, including at least one that will be reirradiated.

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I am 18 years old or older.

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My recurring cancer is within the area previously treated with radiation.

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My stage IV cancer has 3 or fewer lesions, not counting the main tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from nbtxr3 injection to the radiographic confirmation (recist v1.1 and irrecist) of a new lesion outside the lungs and regional nodes or death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from nbtxr3 injection to the radiographic confirmation (recist v1.1 and irrecist) of a new lesion outside the lungs and regional nodes or death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from nbtxr3 injection to the radiographic confirmation (recist v1.1 and irrecist) of a new lesion outside the lungs and regional nodes or death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the Recommended Phase II Dose (RP2D)

Determination of the maximum tolerated dose (MTD)

Incidence of dose limiting toxicity (DLT) Cohort 1

+1 more

Secondary outcome measures

Distant progression free survival (DPFS)

Feasibility of NBTXR3 injection in lung

Feasibility of the regional lymph nodes

+6 more

Other outcome measures

Circulating tumor deoxyribonucleic acid (DNA) mutations

Immune activation

Tumor microenvironment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (NBTXR3, RT)Experimental Treatment2 Interventions

Patients receive NBTXR3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,463 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,213 Total Patients Enrolled

Saumil GandhiPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

213 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04505267 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Treatment (NBTXR3, RT)

Non-Small Cell Lung Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04505267 — Phase 1

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505267 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree could Radiation Therapy be detrimental to an individual's health?

"Radiation Therapy was assigned a score of 1 because there is minimal evidence on its safety and efficacy, as this study is classified as Phase 1."

Answered by AI

Are researchers currently enlisting participants for this trial?

"According to clinicaltrials.gov, this medical trial is presently seeking participants. The first posting was made on the 10th of February 2021 and the most recent amendment occurred on August 3rd 2021."

Answered by AI

What are the main goals of this experiment?

"This trial seeks to assess dose limiting toxicity (DLT) in Cohort 1 over a four-week period post RT. Secondary objectives include measuring overall survival using the Kaplan-Meier method, objective response rate according to RECIST and irRECIST criteria, and local progression free survival also determined with the Kaplan-Meier approach."

Answered by AI

What is the participant figure for this research endeavor?

"Affirmative. According to the clinicaltrials.gov page, this research study first went live on February 10th 2021 and is currently in search of 24 participants across one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer

2021. "NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505267.