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NRG-LU004

Trial

Clinical Trial Title

Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined With MEDI4736 (durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer

Trial Status

Open to Enrollment

Start Date

January 3, 2019

Trial Type

Cancer - Adult Oncology

Specific Condition

Lung Cancer

Description

This phase I trial studies how well giving accelerated hypofractionated or conventionally fractionated radiation therapy and durvalumab works in treating patients with stage II-III non-small cell lung cancer. Accelerated hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventionally fractionated radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving accelerated hypofractionated radiation therapy or conventionally fractionated radiation therapy with durvalumab will work better in treating patients with non-small cell lung cancer.

Eligibility Criteria

Eligibility Criteria

  • Pathologic (cytological or histological) proof of diagnosis of stage II-III (AJCC 8th ed.) unresectable or inoperable, non-metastatic NSCLC within 60 days prior to registration, with no liver or renal end organ damage, as determined by normal laboratory values noted below. Locally recurrent, N1-N3 disease following surgery without prior radiation therapy is eligible. Patients with N1 to N3 and undetectable primary lung tumors (T0) are eligible.
  • Pathological diagnosis of PD-L1 high expressing tumors (≥50%) within 60 days prior to registration (using Dako 22C3 IHC antibody platform) performed at a CLIA-certified lab.
  • ECOG Performance Status of 0-1within 30 days prior to registration

Ineligibility Criteria

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Prior chemotherapy or systemic therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields so that cumulative composite dose combining previous plan and current plan to be within 80 Gy to the trachea, major blood vessels, esophagus, and heart, and 55 Gy to the spinal cord (if such patients are being considered, this will need to be centrally reviewed). Prior chest radiation without overlap is permissible

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


IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, 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 12:56:54 PM