Palliative Thoracic ImmunoRT

Study Overview
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Brief Summary
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The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.

Official Title
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Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer

Conditions
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Lung Cancer, Nonsmall Cell, Lung Cancer

Intervention / Treatment
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* Radiation: Radiation combined with immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10). Receiving or planned to receive nivolumab or pembrolizumab Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks Age 18 or older ECOG Performance Status 0-2 Life expectancy greater than 3 months Able and willing to provide informed consent Able to complete patient reported outcome questionnaires Exclusion Criteria: Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia Previous history of thoracic radiotherapy with an overlapping field Previous history of checkpoint inhibitor related pneumonitis or esophagitis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiation combined with immunotherapy|The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Radiation related toxicities | rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading | up to 24 months | 
| Patient Report Outcome | FACT-E | up to 12 months | 
| Patient experience and anxiety related to Quality of Life | EQ-5D | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Survival |  | 1 year | 
| Rate of Survival |  | 2 year | 
| Rate of Disease Recurrence | Patients will be followed for up to two years following the completion of their radiotherapy. They will undergo CT surveillance imaging as standard by routine immunotherapy protocol with a minimum of 3 scans at the 3, 6 and 12 month mark. Local and distant recurrence will be determined primarily by CTCAE with CT scans as per ir-RECIST v1.0 criteria. | 3, 6, 12 months |