N/A
Completed N=45
Radical RADiotherapy and Immunotherapy for Metastatic CAncer of the Lung (RRADICAL)
Stage IV Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT03176173 ↗
Enrolled (actual)
45
Serious AEs
13.6%
Results posted
Nov 2025
Primary outcomePrimary: Progression-free Survival — 26 Participants — p=0.0007
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
26 | 0.0007 sig |
| SECONDARY Change in Circulating Tumor Deoxyribonucleic Acid Levels as Measured Using CAncer Personalized Profiling by Deep Sequencing |
— | — |
| SECONDARY Change in Immune Marker Levels as Measured From Peripheral Blood Using Flow Cytometry Performed by the Human Immune Monitoring Core at Stanford University |
— | — |
| SECONDARY Number of Participants With Acute (0-6 Months) and Late (> 6 Months) Grade 3-5 Toxicity |
4 | — |
| SECONDARY Overall Survival |
27.4 | — |
Eligibility Criteria
Inclusion Criteria
- Has stage IV non-small cell lung cancer, or initially stage I-III disease with distant metastatic recurrence
- Age ≥ 18
- Has been receiving anti-PD-1 or anti-PD-L1 immunotherapy for at least four weeks (refer to section 4.2.1)
- 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.
- Most recent imaging shows measurable disease as defined by RECIST 1.1
- Evaluation by a Stanford medical oncologist must show:
- The patient is expected to continue on immunotherapy for at least three more months
- Imaging must show response, stable disease, or modest progression
- If there is modest progression, the patient must be clinically stable in terms of performance status and overall disease-related symptoms
- Has at least one extracranial tumor safely treatable with radical-dose radiation therapy and that has not been previously treated with radiation
- ECOG performance status 0-2
- 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
Data sourced from ClinicalTrials.gov (NCT03176173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.