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Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC

NCT03818776 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-02-15

No results posted yet for this study

Summary

The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. This may be advantageous in treating lung cancer because it allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.

Conditions

Interventions

DRUG

Durvalumab

Durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody immunotherapy for lung cancer. Participants will receive 1500mg durvalumab via intravenous (IV) infusion Q4W for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48 unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. (N.b. If a participant's weight falls to 30kg (≤30 kg)), then the participant should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W after consultation between Investigator and Study Physician, until the weight improves to above 30 kg \>30 kg, at which point the participant should start receiving the fixed dosing of durvalumab 1500 mg Q4W).

RADIATION

Proton beam therapy RT

Proton beam therapy is a type of RT where the proton stops at a specific depth according to its energy which allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Debora Bruno, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2022-01-27
Completion
2022-01-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03818776 on ClinicalTrials.gov