Non Small Cell Lung CancerPhase 2NCT07777614
OPTIMISE Lung SABR
A Phase 2 study testing Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment and Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) in people with Non Small Cell Lung Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
Trial summary
This study is a phase II multi-centre, randomised study independently evaluating five fraction Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours, or a peripherally located single pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment and Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2026to Jun 2035
- Phase
- Phase 2
- 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
Who may be able to join
- Written informed consent obtained prior to any study-specific procedures.
- ≥ 18 years of age.
- Life expectancy >6 months.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
- Histological diagnosis (biopsy or cytology) or radiological diagnosis (tumour which meets definition of 'measurable' per RECIST criteria and eligible for local ablative therapy per multi-disciplinary team (MDT) recommendations) of either:
- Primary Non-Small Cell Lung Cancer (squamous cell carcinoma, adenocarcinoma, large cell): T1-T2 N0 M0 tumour (AJCC 8th edition) and selected T3 and T4 N0M0 which has only one lesion (a co-existing lesion unlikely to interfere with treatment or assessment of outcomes is permitted) to be treated for the purpose of the study OR (ii) Single pulmonary oligometastatic lesion to be treated for the purpose of the study.
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- (Note: for (i) and (ii), a co-existing lesion(s) unlikely to interfere with treatment or assessment of outcomes is (are) permitted).
- Patients with peripherally located tumours, defined as tumours not fulfilling the UK 2022 SABR Consortium Consensus optimal 3 fraction constraints for Chest wall (0.1 cc <36.9 Gy) or (30 cc < 30 Gy), with standard Planning Target Volume (PTV) coverage due to the proximity of their tumour to the chest wall , but which are predicted to meet the CTRIAL-IE 24-15 OPTIMISE Lung SABR Study dose volume constraints with dose escalation optimised to the Gross Tumour Volume (GTV).
- Inoperable (as per MDT) or patient refuses surgery.
- People of childbearing potential must not be pregnant or lactating and must be prepared to take adequate contraception methods during treatment. People whose partners are of child-bearing potential must be prepared to take adequate contraception methods during treatment.
- Absence of psychological, familial, sociological, or geographical condition, or psychiatric illness/social situation potentially hampering compliance with the study protocol and follow-up schedule
Who cannot join
- Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma which is likely to interfere with treatment or assessment of outcomes.
- Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC.
- Malignant spinal canal involvement.
- Patients with syndromes or conditions associated with increased radiosensitivity.
- Idiopathic pulmonary fibrosis / usual interstitial pneumonia.
- Chemotherapy and/or other targeted therapy administered within 3 months prior to study radiotherapy (RT) or planned for <6 weeks following RT for patients with primary NSCLC, or within 1 week prior to study RT or planned within 1 week following RT for patients with an oligometastatic lesion.
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- Any previous RT to the thorax or mediastinum (excluding previous breast or Chest Wall RT) which is likely to interfere with treatment or assessment of outcomes.
- Any tumour not clinically definable on the treatment planning CT scan (e.g. surrounding consolidation or atelectasis).
- Patients unable to undergo 4-Dimensional Computed Tomography (4DCT scan).
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research/ medical team that the patient may not be able to comply with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Trials Ireland RCSI House, 121 St Stephen's Green, Dublin 2 contact
Ireland1 site, 1 recruiting
- Recruiting
St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital and St James's Hospital
Dublin, D06 HH36
CTI, +353 1 406 5000, info@cancertrials.ie
Pierre Thirion
About this study
Official title: OPTIMISation of pEripheral Lung Stereotactic Ablative Body Radiotherapy, a Prospective Independent Evaluation of 3 Fraction and 5 Fraction SABR Regimens (OPTIMISE Lung SABR)
This study is a phase II multi-centre, randomised study independently evaluating five fraction Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours, or a peripherally located single pulmonary oligometastatic lesion.
Read the detailed description
This study is for patients who have a lung tumour located near the ribs or chest wall, and who are not suitable for surgery. Currently, these patients are usually treated with Stereotactic Ablative Radiotherapy (SABR). SABR is a precise form of radiotherapy that delivers high doses of radiation to the tumour while protecting surrounding healthy tissue. The standard treatment for these patients currently is 60 Gray (Gy) in 5 treatments (12 Gy each), spread over about 2 weeks. This schedule is thought to reduce the risk of rib fractures and is currently adopted when a patient has a tumour located near the ribs or chest wall.
This study is testing whether an alternative investigational treatment schedule, 54 Gy in 3 treatments (18 Gy each) given over about 1 week, is just as safe and effective for these patients.
This new approach means patients would need to attend the hospital for two fewer visits. A new method of SABR planning for the alternative treatment schedule makes it possible to direct the radiation dose straight to the tumour while avoiding the ribs and chest wall as much as possible. Because of this planning method, the research team believes the investigational three-treatment schedule will not increase side effects such as rib fractures or chest wall pain compared with the standard five-treatment schedule.
SABR is already widely used in many types of cancer. It works by delivering higher doses of radiation over fewer treatment sessions. This can be more effective than conventional external beam radiotherapy where treatment is delivered over 4-6 weeks in some cases and is often more convenient for patients.
In this study, patients will be randomly assigned to receive either: Arm 1: Regimen of 60 Gy in 5 treatments over approximately two weeks, or Arm 2: Investigational regimen of 54 Gy in 3 treatments over approximately 1 week. Treatments in both groups are given on weekdays only, with at least forty hours between each session.
The technology used in SABR allows very precise targeting of the tumour while protecting nearby healthy organs such as the heart, spinal cord and normal lung tissue. The planning process also accounts for the natural movement of the lungs during breathing. Before each treatment, a cone beam CT scan is used to ensure the patient is in the correct position. The purpose of the study is to see how well each treatment schedule controls lung tumours and what side effects patients experience. It will also explore what factors might influence whether side effects such as rib fractures or chest wall pain occur. The enrolment period is expected to be approximately 3.5 years. Toxicity assessments will be carried out weekly during radiotherapy (RT), at 4 and 8-weeks post-treatment and at 3, 6, 9, 12, 18, 24 months post-treatment and annually thereafter to 5 years post treatment.
Translational Sub-Study: (Raman spectroscopic analysis) - Primary aim is to undertake biomarker discovery using label-free Raman spectroscopy coupled with multivariate statistical methods to identify spectral biomarkers that could:
- Predict response based on individual radiation sensitivity
- Monitor response based on individual radiation sensitivity
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment, Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
- Keywords
- Lung cancer, Non-small cell lung cancer, Peripheral, Stereotactic Ablative Body Radiotherapy (SABR), Radiotherapy, Oligometastatic cancer, Single lung lesion
- 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.
Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatmentRadiation
IG-SABR using a total of 5 fractions (12 Gy per fraction) to a total dose of 60 Gy prescribed to 95% of the Planning Target Volume (PTV).
Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)Radiation
IG-SABR using a total of 3 fractions (18 Gy per fraction) to a total dose of 54 Gy prescribed to 99% of the Gross Tumour Volume (GTV) with a minimum dose of 49.7 Gy to 95% of the Planning Tumour Volume (PTV) and 48 Gy to 99% of the PTV (i.e. 'optimised' three fraction SABR)
| Study group | Role | What they receive |
|---|---|---|
| Five fraction IG-SABR | Active comparator | Five fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) Receives: Radiation: Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment |
| Three fraction IG-SABR | Experimental | Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) Receives: Radiation: Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of ≥ Grade 3 treatment-related Adverse Events (TxR)-AEs/toxicities using NCI CTCAE V5.
The incidence of treatment-related adverse events (TxR-AEs) of Grade ≥3 will be assessed separately for the three-fraction and five-fraction stereotactic ablative radiotherapy (SABR) regimens in patients with inoperable, peripherally located tumours. The incidence will be calculated as the proportion of evaluable patients experiencing at least one Grade ≥3 TxR-AE, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, from the start of radiotherapy through 2 years following treatment. For each treatment arm, the proportion and corresponding 95% confidence interval will be reported based on the total number of evaluable patients. Descriptive summaries will include patient disposition, reasons for exclusion from analysis, baseline and pre-treatment characteristics, and the frequency and severity of adverse events.
Measured: From start of treatment to 2 years post treatment
Secondary outcomes (12)
Acute toxicity profiles of Grade ≥2 treatment-related toxicities.
Acute toxicity rates of Grade ≥2 for each arm, using NCI CTCAE V5 at the end of Radiotherapy (RT), 4 weeks, 8 weeks and 3 months post-RT.
Measured: Up to 3 months post treatment
Late toxicity profiles of Grade ≥2 treatment-related toxicities
Late toxicity rates of Grade ≥2 for each arm, using NCI CTCAE V5 at 6, 9, 12, 18, 24, 36, 48 and 60 months post-RT.
Measured: From 3 months to 5 years post-treatment
Treatment-related 2-year cumulative rate of NCI CTCAE V5 Grade ≥2 Chest Wall toxicity and Rib fracture for the three fraction and five fraction regimens.
The incidence of NCI CTCAE V5 Grade ≥2 treatment-related Chest wall, and Rib fracture toxicities, for each arm, independently. These calculations include 95% confidence Intervals. Chest wall toxicity consists of a combination of symptoms; a full list of considered toxicities will be documented in the Statistical Analysis Plan.
Measured: Up to 2 years post treatment
Time to onset of acute and late Grade ≥2 and Grade ≥3 study treatment related toxicities.
For each arm, time-to-event analyses will be conducted separately for time to onset of acute and late NCI CTCAE V5 grade ≥2 and grade ≥3 toxicities which are related to trial treatments. Evaluable Patients who have been lost to follow-up, withdrawn, or have not experienced the event by the time of analysis will be censored at their last available toxicity assessment.
Measured: Up to 5 years post-treatment
Recurrence/progression free and survival outcomes following treatment.
Assessment of local recurrence/progression, locoregional recurrence-free survival, disease-free survival, and metastasis-free outcomes following stereotactic ablative radiotherapy (SABR) in patients receiving either the three-fraction or five-fraction regimen. For patients with primary non-small cell lung cancer (NSCLC), metastasis-free survival will be evaluated. For patients with peripheral oligometastatic lesions, further metastasis-free survival will be evaluated. Outcomes will be assessed using computed tomography (CT), positron emission tomography (PET), and/or biopsy as clinically indicated. Kaplan-Meier methods will be used to estimate time-to-event distributions, median survival times, and event-free survival rates at 1, 3, and 5 years, with 95% confidence intervals where estimable.
Measured: Up to 5 years post-treatment.
Overall survival.
For each treatment arm, the overall survival time at 1 year, 3 years, and 5 years. For overall survival, the event is death due to any cause. Evaluable patients who have lost follow-up, withdrawn, or have not experienced the event by the time of analysis will be censored at their last available assessment.
Measured: Up to 5 years post-treatment.
Local post treatment response and outcomes (Local Tumour Control).
Local Tumour Control using CT and Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months. Only patients who received the prescribed RT dose and who are alive at the specified CT timepoints during follow up will be evaluated for tumour response and included in the analysis of tumour response rates for each arm independently. The tumour response will be analysed by calculating the proportion of patients showing a response (Local Tumour Progression) at the specified CT timepoints, presented with corresponding 95% confidence intervals.
Measured: From end of treatment up to 5 years post-treatment
Treatment Tolerability and Feasibility of Three-Fraction and Five-Fraction SABR
The compliance rate for each treatment delivery in accordance with the protocol prescription. Additionally, the number of treatment withdrawals provide further insight into the tolerability and feasibility of the treatment regimens.
Measured: From end of treatment up to 5 years post-treatment.
Post-Treatment forced expiratory volume in one second (FEV1) change relative to baseline
Calculation of the difference in forced expiratory volume in one second (FEV1) from baseline to 6 months, 12 months and annually thereafter for each arm. Descriptive statistics, including mean, standard deviation, median, and range, characterise the changes in forced expiratory volume in one second (FEV1) before and after treatment in each group. Additionally, paired t-tests or non-parametric equivalents (such as the Wilcoxon signed-rank test) evaluate the statistical significance of the changes from baseline at each time point.
Measured: Up to 5 years post- treatment
Post-Treatment Diffusion Capacity Change Relative to Baseline
Calculation of the differences in diffusion capacity from baseline to 6 months, 12 months and annually thereafter for each arm. Descriptive statistics, including mean, standard deviation, median, and range, characterise the change in diffusion capacity, before and after treatment in each group. Additionally, paired t-tests or non-parametric equivalents (such as the Wilcoxon signed-rank test) evaluate the statistical significance of the changes from baseline at each time point.
Measured: Up to 5 years post- treatment
Fracture Risk adjusted for Baseline Bone Density Score.
Measure the proportion of patients with fractures during the follow-up period, stratified by baseline bone density categories (normal, osteopenia, osteoporosis) for each regimen. Additionally, use the Cox proportional hazards model to calculate the hazard ratio (HR) for fracture risk across different baseline bone density scores within each regimen
Measured: Up to 5 years post-treatment
Post RT Quality of Life (QoL) relative to baseline using EORTC QLQC30 questionnaire.
Scoring for European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 will be performed using the standard method proposed by Giesinger, Kieffer, et al., 2016. Descriptive statistics, including the mean and SD of the overall scores and the domain- and symptom-specific scores for EORTC QLQ-C30, will be reported at baseline, 6, 12 and 24 months post-RT. Changes in scores over time for each patient will be calculated by subtracting the baseline results from those at the 6, 12 and 24 month follow-up. The mean and SD of these changes will be reported, and a Wilcoxon signed rank-test will be used to compare differences from baseline. Furthermore, there will be an assessment of the number of patients experiencing a clinically meaningful change in quality of life. This analysis will be conducted for each arm separately.
Measured: Up to 24 months post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026
- Primary completionDec 2029 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Collaborators
- Focas Research Institute, Technological University Dublin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777614
- Sponsor's protocol ID
- CTRIAL 24-15
- Status last verified
- Oct 2026
- First submitted
- 28 May 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMISation of pEripheral Lung Stereotactic Ablative Body Radiotherapy, a Prospective Independent Evaluation of 3 Fraction and 5 Fraction SABR Regimens (OPTIMISE Lung SABR)
- ClinicalTrials.gov ID
- NCT07777614
- Acronym / sponsor ID
- CTRIAL 24-15
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung cancer, Non-small cell lung cancer, Peripheral, Stereotactic Ablative Body Radiotherapy (SABR), Radiotherapy, Oligometastatic cancer, Single lung lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Collaborators
- Focas Research Institute, Technological University Dublin
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 20 Aug 2026 (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.
This study is a phase II multi-centre, randomised study independently evaluating five fraction Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours, or a peripherally located single pulmonary oligometastatic lesion.
Detailed description
This study is for patients who have a lung tumour located near the ribs or chest wall, and who are not suitable for surgery. Currently, these patients are usually treated with Stereotactic Ablative Radiotherapy (SABR). SABR is a precise form of radiotherapy that delivers high doses of radiation to the tumour while protecting surrounding healthy tissue. The standard treatment for these patients currently is 60 Gray (Gy) in 5 treatments (12 Gy each), spread over about 2 weeks. This schedule is thought to reduce the risk of rib fractures and is currently adopted when a patient has a tumour located near the ribs or chest wall.
This study is testing whether an alternative investigational treatment schedule, 54 Gy in 3 treatments (18 Gy each) given over about 1 week, is just as safe and effective for these patients.
This new approach means patients would need to attend the hospital for two fewer visits. A new method of SABR planning for the alternative treatment schedule makes it possible to direct the radiation dose straight to the tumour while avoiding the ribs and chest wall as much as possible. Because of this planning method, the research team believes the investigational three-treatment schedule will not increase side effects such as rib fractures or chest wall pain compared with the standard five-treatment schedule.
SABR is already widely used in many types of cancer. It works by delivering higher doses of radiation over fewer treatment sessions. This can be more effective than conventional external beam radiotherapy where treatment is delivered over 4-6 weeks in some cases and is often more convenient for patients.
In this study, patients will be randomly assigned to receive either: Arm 1: Regimen of 60 Gy in 5 treatments over approximately two weeks, or Arm 2: Investigational regimen of 54 Gy in 3 treatments over approximately 1 week. Treatments in both groups are given on weekdays only, with at least forty hours between each session.
The technology used in SABR allows very precise targeting of the tumour while protecting nearby healthy organs such as the heart, spinal cord and normal lung tissue. The planning process also accounts for the natural movement of the lungs during breathing. Before each treatment, a cone beam CT scan is used to ensure the patient is in the correct position. The purpose of the study is to see how well each treatment schedule controls lung tumours and what side effects patients experience. It will also explore what factors might influence whether side effects such as rib fractures or chest wall pain occur. The enrolment period is expected to be approximately 3.5 years. Toxicity assessments will be carried out weekly during radiotherapy (RT), at 4 and 8-weeks post-treatment and at 3, 6, 9, 12, 18, 24 months post-treatment and annually thereafter to 5 years post treatment.
Translational Sub-Study: (Raman spectroscopic analysis) - Primary aim is to undertake biomarker discovery using label-free Raman spectroscopy coupled with multivariate statistical methods to identify spectral biomarkers that could:
- Predict response based on individual radiation sensitivity
- Monitor response based on individual radiation sensitivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Five fraction IG-SABR | Active comparator | Radiation: Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatmentFive fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) |
| Three fraction IG-SABR | Experimental | Radiation: Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained prior to any study-specific procedures.
- ≥ 18 years of age.
- Life expectancy >6 months.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
- Histological diagnosis (biopsy or cytology) or radiological diagnosis (tumour which meets definition of 'measurable' per RECIST criteria and eligible for local ablative therapy per multi-disciplinary team (MDT) recommendations) of either:
Key exclusion criteria (11 listed)
- Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma which is likely to interfere with treatment or assessment of outcomes.
- Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC.
- Malignant spinal canal involvement.
- Patients with syndromes or conditions associated with increased radiosensitivity.
- Idiopathic pulmonary fibrosis / usual interstitial pneumonia.
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 |
|---|---|---|
| Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatmentIG-SABR using a total of 5 fractions (12 Gy per fraction) to a total dose of 60 Gy prescribed to 95% of the Planning Target Volume (PTV). | Radiation | Five fraction IG-SABR |
| Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)IG-SABR using a total of 3 fractions (18 Gy per fraction) to a total dose of 54 Gy prescribed to 99% of the Gross Tumour Volume (GTV) with a minimum dose of 49.7 Gy to 95% of the Planning Tumour Volume (PTV) and 48 Gy to 99% of the PTV (i.e. 'optimised' three fraction SABR) | Radiation | Three fraction IG-SABR |
Primary outcome
To assess the incidence of ≥ Grade 3 treatment-related Adverse Events (TxR)-AEs/toxicities using NCI CTCAE V5.
Time frame: From start of treatment to 2 years post treatment
The incidence of treatment-related adverse events (TxR-AEs) of Grade ≥3 will be assessed separately for the three-fraction and five-fraction stereotactic ablative radiotherapy (SABR) regimens in patients with inoperable, peripherally located tumours. The incidence will be calculated as the proportion of evaluable patients experiencing at least one Grade ≥3 TxR-AE, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, from the start of radiotherapy through 2 years following treatment. For each treatment arm, the proportion and corresponding 95% confidence interval will be reported based on the total number of evaluable patients. Descriptive summaries will include patient disposition, reasons for exclusion from analysis, baseline and pre-treatment characteristics, and the frequency and severity of adverse events.
12 secondary outcomes
Acute toxicity profiles of Grade ≥2 treatment-related toxicities.
Time frame: Up to 3 months post treatment
Late toxicity profiles of Grade ≥2 treatment-related toxicities
Time frame: From 3 months to 5 years post-treatment
Treatment-related 2-year cumulative rate of NCI CTCAE V5 Grade ≥2 Chest Wall toxicity and Rib fracture for the three fraction and five fraction regimens.
Time frame: Up to 2 years post treatment
Time to onset of acute and late Grade ≥2 and Grade ≥3 study treatment related toxicities.
Time frame: Up to 5 years post-treatment
Recurrence/progression free and survival outcomes following treatment.
Time frame: Up to 5 years post-treatment.
Overall survival.
Time frame: Up to 5 years post-treatment.
Local post treatment response and outcomes (Local Tumour Control).
Time frame: From end of treatment up to 5 years post-treatment
Treatment Tolerability and Feasibility of Three-Fraction and Five-Fraction SABR
Time frame: From end of treatment up to 5 years post-treatment.
Post-Treatment forced expiratory volume in one second (FEV1) change relative to baseline
Time frame: Up to 5 years post- treatment
Post-Treatment Diffusion Capacity Change Relative to Baseline
Time frame: Up to 5 years post- treatment
Fracture Risk adjusted for Baseline Bone Density Score.
Time frame: Up to 5 years post-treatment
Post RT Quality of Life (QoL) relative to baseline using EORTC QLQC30 questionnaire.
Time frame: Up to 24 months post-RT
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Cancer Trials Ireland RCSI House, 121 St Stephen's Green, Dublin 2 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment and Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) in people with Non Small Cell Lung Cancer, run by Cancer Trials Ireland at 1 site in Ireland.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Oct 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 Ireland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Cancer Trials Ireland RCSI House, 121 St Stephen's Green, Dublin 2 (+353 1 667 7211, info@cancertrials.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of ≥ Grade 3 treatment-related Adverse Events (TxR)-AEs/toxicities using NCI CTCAE V5. (time frame: From start of treatment to 2 years post treatment). 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 16 Oct 2026.