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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation combined with immunotherapy | Radiation | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Survival | 1 year | |
| Rate of Survival | 2 year | |
| Rate of Disease Recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include a population of patients with metastatic NSCLC on first or second line immunotherapy who have an indication for palliative thoracic radiation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network, Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Study procedures include blood draw at baseline, end of radiation treatment, and at 1 month follow up visit.
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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |