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Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

NCT03035890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-01

Study results available
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Summary

This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

Conditions

  • Non Small Cell Lung Cancer Metastatic

Interventions

RADIATION

Radiation

Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy)

DRUG

Immuno-Therapeutic Agent

Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • West Virginia Clinical and Translational Science Institute

    collaborator OTHER

  • West Virginia University

    lead OTHER

Principal Investigators

  • Mohammad Shaikh, MD · West Virginia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035890 on ClinicalTrials.gov