©2022 Stanford Medicine
Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy
Not Recruiting
Trial ID: NCT03176173
Purpose
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
Clinical Associate Professor, Radiation Oncology - Radiation Therapy
Heather Wakelee
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Maximilian Diehn, MD, PhD
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
Billy W Loo, Jr, MD PhD FASTRO FACR
Professor of Radiation Oncology (Radiation Therapy)
Eligibility
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
months
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
document.
Exclusion Criteria:
- Untreated brain metastases, if not planned to be treated in this course of radiation
therapy
- Pregnancy or women of childbearing potential not willing/able to use contraception
during protocol treatment
Intervention(s):
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
650-497-8966