Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.
Pathologic diagnosis of Non-Small Cell Lung Cancer (NSCLC) without targetable/oncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement).
T1-4(or Tx)N0-3M1a-c, Stage IV disease (using the 8th edition of the AJCC staging manual) or metastatic recurrence of primary Stage I-III NSCLC that had been treated with curative intent therapy, without prior thoracic radiotherapy.
Thoracic lung and/or nodal lesion(s) amenable to palliative chest radiotherapy.
All subjects are required to have one or more of the following high-risk features: a) a non-central primary lung lesion ≥5 cm in size (at least T3 by criteria); b) bulky (≥2 cm) parenchymal lung lesions and/or nodal lesions abutting (within 1 cm) any of the following: Proximal bronchial tree, Esophagus, Vertebra, Heart, brachial plexus or subclavian vessels (if brachial plexus not well visualized), Superior vena cava
Prior radiation therapy to the thoracic region.
Active systemic lupus or Sjogren's disease.
NSCLC (primary, nodal sites or metastases) causing severe symptoms requiring thoracic palliative radiotherapy for indications other than bone pain. These symptoms include superior vena cava syndrome, active and large volume (>100 ml per day) hemoptysis, airway obstruction (stridor, post-obstructive pneumonia, progressive dyspnea not attributed to other causes), compression of the spinal cord or spinal nerve roots, vertebral compression fracture, brachial plexopathy (from compression).
Baseline ECOG performance status of 3-4. For the purposes of eligibility, Karnofsky Performance Score (KPS) will be converted to ECOG/Zubrod performance score, per ECOG guidelines.
Single group
Prophylactic Palliative Radiotherapy
RadiationProphylactic Palliative Radiotherapy
Freedom from symptomatic progression of irradiated thoracic target(s)
Kaplan-Meier freedom from symptomatic progression of irradiated thoracic target(s) at 6 months, 1 year, and 2 years.
OS (Kaplan-Meier) (Kaplan-Meier)
Kaplan Meier Overall Survival
Freedom from local recurrence of irradiated thoracic target lesion(s)
Freedom from local recurrence of irradiated thoracic target lesion(s)
PFS (freedom from local and distant progression; Kaplan-Meier)
Progression (local or distant) free survival Outcome
Duration of time that patient is maintenance
Duration of time that patient remains on maintenance systemic therapy
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