Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03867175
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Lung Cancer
  • Stage IV Lung Cancer

Eligibility Criteria

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

Interventions

  • Stereotactic Body Radiation Therapy — RADIATION
    Patients undergo 3-10 treatments of stereotactic body radiation therapy (SBRT)
  • Pembrolizumab — BIOLOGICAL
    Patients undergo 3-10 treatments of SBRT. Patients also receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.

Study Details

This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throughout the body) in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving immunotherapy with stereotactic body radiation therapy may work better than immunotherapy alone in treating patients with non-small cell lung cancer.

Key Dates

Start date
Jun 24, 2019
Status verified
May 2025
Primary completion
Apr 21, 2025
Completion
Apr 21, 2025

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab
    3-10 treatments of SBRT/ pembrolizumab IV for 30 minutes every 3-4 weeks for 1 year at doctor's discretion.
  • Experimental: Arm 2 Pembrolizumab Only
    Patients receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.

Primary Outcome Measure

Number of Participants With Progression-free Survival (PFS) After Completion of First Line Standard of Care Systemic Therapy [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-

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By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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