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SWOG S1914

Trial

Clinical Trial Title

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Trial Status

Open to Enrollment

Start Date

September 2, 2020

Trial Type

Cancer - Adult Oncology

Specific Condition

Lung Cancer

Description

This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as 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 atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Eligibility Criteria

Eligibility Criteria

  • Patient must have histologically or cytologically proven Stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC)
  • Patient must have undergone diagnostic chest CT with contrast (unless medically contraindicated) within 42 days prior to randomization.
  • Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization.
  • Patient must not have evidence of hilar or mediastinal nodal involvement.
  • Patient must have undergone history and physical examination within 28 days prior to randomization.
  • Patient must not have received any prior treatment for NSCLC.
  • Patient must not have undergone prior radiation to overlapping regions of the chest
  • Patient must be ≥ 18 years old.
  • Patient must have Zubrod Performance Status of 0-2
  • Patient must not have myocardial infarction within 90 days prior to randomization.
  • Patient must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized prostate cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:57:04 PM