Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy

Not Recruiting

Trial ID: NCT03176173


This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with non-small cell lung cancer that has spread to other places in the body who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with non-small cell lung cancer may help to improve response to immunotherapy anti-cancer treatment.

Official Title

Radical RADiotherapy and Immunotherapy for Metastatic CAncer of the Lung (RRADICAL)

Stanford Investigator(s)

Michael Gensheimer
Michael Gensheimer

Clinical Associate Professor, Radiation Oncology - Radiation Therapy

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)


Professor of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   1. Has stage IV non-small cell lung cancer, or initially stage I-III disease with distant
   metastatic recurrence

   2. Age ≥ 18

   3. Has been receiving anti-PD-1 or anti-PD-L1 immunotherapy for at least four weeks
   (refer to section 4.2.1)

   4. Has had restaging imaging after initiation of immunotherapy, at least 4 weeks after
   pre-immunotherapy baseline imaging. CT or PET/CT of at least chest/upper abdomen must
   be performed within 4 weeks prior to registration. For patients with history of brain
   metastases, brain MRI or CT is required within 4 weeks of registration; for other
   patients brain MRI or CT is required within 12 weeks of registration. Diagnostic
   PET/CT performed as part of radiation simulation can be used as the restaging imaging.

   5. Most recent imaging shows measurable disease as defined by RECIST 1.1

   6. Evaluation by a Stanford medical oncologist must show:

      1. The patient is expected to continue on immunotherapy for at least three more

      2. Imaging must show response, stable disease, or modest progression

      3. If there is modest progression, the patient must be clinically stable in terms of
      performance status and overall disease-related symptoms

   7. Has at least one extracranial tumor safely treatable with radical-dose radiation
   therapy and that has not been previously treated with radiation

   8. ECOG performance status 0-2

   9. Has the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

   - Untreated brain metastases, if not planned to be treated in this course of radiation

   - Pregnancy or women of childbearing potential not willing/able to use contraception
   during protocol treatment


radiation: Image-guided Radiation Therapy

drug: Immunotherapy (physician's choice for standard of care immunotherapy)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kim Nguyen

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