Treating Early-stage Non-Small Cell Lung Cancer With Durvalumab and Radiation Therapy

Part of paid clinical trials in Miami, Florida.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04716946
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Patients will receive durvalumab 1500mg durvalumab via IV infusion over 1 hour, once every 4 weeks (Q4W) for up to a maximum of 6 months (up to 6 doses/cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
  • Stereotactic Body Radiation Therapy — RADIATION
    Radiation therapy will be performed with external beam ionizing radiation in accordance with institutional standard practice. 3D conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) will be used at the discretion of the treating radiation oncologist.

Study Details

The purpose of this study is to find out whether treatment with the study drug durvalumab combined with a type of radiation therapy called stereotactic body radiation (SBRT) is a more effective treatment for early-stage non-small cell lung cancer (NSCLC) than SBRT alone.

Key Dates

Start date
Jan 27, 2021
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Early-stage Non-Small Cell Lung Cancer
    Participants will be diagnosed with Stage I-IIIA NSCLC and will be ineligible for surgery and will have any level of PD-L1

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Baptist Alliance - McIMiamiFlorida33143-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center @ Suffolk - CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauRockville CentreNew York11553-

Find similar trials in Miami, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Baptist Alliance - McI· Miami, FLMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk - Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NY

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