Lung Cancer, Nonsmall CellNCT03705806
Palliative Thoracic ImmunoRT
An observational study of Lung Cancer, Nonsmall Cell and Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Lung Cancer
- What is being tested?
- Radiation combined with immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2018to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Show all 9Show fewer
- Life expectancy greater than 3 months
- Able and willing to provide informed consent
- Able to complete patient reported outcome questionnaires
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
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
- Lung Cancer, Nonsmall Cell, Lung Cancer
- Being tested
- Radiation combined with immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation combined with immunotherapyRadiation
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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of Radiation related toxicities
rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading
Measured: up to 24 months
Patient Report Outcome
FACT-E
Measured: up to 12 months
Patient experience and anxiety related to Quality of Life
EQ-5D
Measured: up to 12 months
Secondary outcomes (3)
Rate of Survival
Measured: 1 year
Rate of Survival
Measured: 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.
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start3 Oct 2018
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705806
- Sponsor's protocol ID
- 18-5327
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2018
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03705806
- Acronym / sponsor ID
- 18-5327
- Conditions
- Lung Cancer, Nonsmall Cell, Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation combined with immunotherapyThe 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. | Radiation | – |
Primary outcome
Rate of Radiation related toxicities
Time frame: up to 24 months
rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading
Patient Report Outcome
Time frame: up to 12 months
FACT-E
Patient experience and anxiety related to Quality of Life
Time frame: up to 12 months
EQ-5D
3 secondary outcomes
Rate of Survival
Time frame: 1 year
Rate of Survival
Time frame: 2 year
Rate of Disease Recurrence
Time frame: 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer, Nonsmall Cell
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Lung Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Non-small Cell Lung Cancer (NSCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Nonsmall Cell and Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Radiation related toxicities (time frame: up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.