Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT03818776
Phase
EARLY_PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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).
  • Proton beam therapy RT — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Aug 30, 2019
Status verified
Feb 2024
Primary completion
Jan 27, 2022
Completion
Jan 27, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - 60 CGyE in 20 fractions
    Proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 60 CGyE in 20 fractions (3+3 participants, 3-6 total)
  • Experimental: Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort a
    Proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants)

Primary Outcome Measure

Safety of intervention as defined by number of participants with Dose Limiting Toxicities (DLT) between first dose of Durvalumab and 30 days following completion of radiotherapy. [ Time Frame: Up to 30 days following end of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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