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

Trial ID or NCT#

NCT03176173

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Has stage IV non-small cell lung cancer, or initially stage I-III disease with distant metastatic recurrence2. Age ≥ 183. 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 1.16. Evaluation by a Stanford medical oncologist must show:
  2. 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 symptoms7. Has at least one extracranial tumor safely treatable with radical-dose radiation therapy and that has not been previously treated with radiation8. ECOG performance status 0-29. Has the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
  1. * 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
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Investigator(s)

Michael Gensheimer
Michael Gensheimer
Radiation oncologist
Clinical Associate Professor, Radiation Oncology - Radiation Therapy
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
Joel Neal, MD, PhD
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Associate Professor of Medicine (Oncology)
Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD
Radiation oncologist
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
Billy W Loo, Jr, MD PhD FASTRO FACR
Billy W Loo, Jr, MD PhD FASTRO FACR
Radiation oncologist, Thoracic specialist
Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Kim Nguyen
650-497-8966

View on ClinicalTrials.gov