Clinical trial · Observational
Palliative Thoracic ImmunoRT
Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
NCT03705806CI-TRIAL-00104578active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation combined with immunotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Rate of Radiation related toxicities
- timeFrame
- up to 24 months
- description
- rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading
- measure
- Patient Report Outcome
- timeFrame
- up to 12 months
- description
- FACT-E
- measure
- Patient experience and anxiety related to Quality of Life
- timeFrame
- up to 12 months
- description
- EQ-5D
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment. 2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10). 3. Receiving or planned to receive nivolumab or pembrolizumab 4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks 5. Age 18 or older 6. ECOG Performance Status 0-2 7. Life expectancy greater than 3 months 8. Able and willing to provide informed consent 9. Able to complete patient reported outcome questionnaires Exclusion Criteria: 1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia 2. Previous history of thoracic radiotherapy with an overlapping field 3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis 4. Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.