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Off-Protocol Radiotherapy in Prospective Systemic Therapy Trials for Metastatic Non-Small Cell Lung Cancer
Kara M Ruicci1, George J Li1, Andrew Warner2
1Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada.
Clinical Lung Cancer
|June 18, 2026
Summary
Radiotherapy use is common in metastatic non-small cell lung cancer (NSCLC) trials, but details are inconsistently reported. Future trials need clear radiation parameters to improve data accuracy and patient outcomes.
Area of Science:
- Oncology
- Clinical Trials
- Radiation Oncology
Background:
- Radiotherapy is frequently used for metastatic non-small cell lung cancer (NSCLC) to manage symptoms and treat metastases.
- Emerging evidence suggests radiotherapy can influence the course of metastatic NSCLC.
Purpose of the Study:
- To examine protocol specifications for radiation use in prospective systemic therapy trials for metastatic NSCLC.
- To assess the documentation of radiation exposure before and during trial enrollment.
Main Methods:
- A systematic review of completed phase II-IV systemic therapy trials for metastatic NSCLC was conducted using ClinicalTrials.gov.
- Descriptive statistics were used to summarize trial characteristics, and Fisher's exact test/logistic regression analyzed associations between radiation allowance and trial outcomes.
Main Results:
- Of 79 included trials, most were phase III, randomized, and unmasked, targeting PD-1/PD-L1, EGFR, or VEGF.
- While most trials allowed prior radiation, few specified washout periods or prohibited concurrent radiation.
- No studies detailed radiation parameters for off-protocol use, and its allowance was not linked to trial success.
Conclusions:
- Prospective systemic therapy trials for NSCLC often lack consistent reporting of radiotherapy details.
- Clear guidelines for radiation use before and during trials are essential due to overlapping toxicities and radiotherapy's common application in NSCLC.
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