A Phase 2 interventional study of Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment and Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) in Non Small Cell Lung Cancer, sponsored by Cancer Trials Ireland. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Cancer Trials Ireland · Phase 2, Interventional, and Treatment
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.
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:
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 208 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Cancer Trials Ireland is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Histological diagnosis ( or cytology) or radiological diagnosis (tumour which meets definition of 'measurable' per criteria and eligible for local ablative therapy per multi-disciplinary team (MDT) recommendations) of either:
(i) 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.
(Note: for (i) and (ii), a co-existing lesion(s) unlikely to interfere with treatment or assessment of outcomes is (are) permitted).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Five fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
Radiation: Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment
Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
Radiation: Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
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).
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)
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.
Time frame: From start of treatment to 2 years post treatment
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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to 24 months post-RT
Plan to share: No
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