Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT06191250
--SuPERIOR Trial--
A Phase 2 study testing Durvalumab and Non-ablative oligofractionated radiation (NORT) in people with Non-Small Cell Lung Cancer (NSCLC) and Clinical Staging T2b-3 N0-1 M0, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The Window-of-Opportunity (WOO) Network is a collaboration among Ontario's doctors and scientists to conduct clinical trials in newly-diagnosed cancer patients before they have surgery with an initial focus on understanding how cancer drugs can impact the immune system. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Clinical Staging T2b-3 N0-1 M0
- What is being tested?
- Durvalumab and Non-ablative oligofractionated radiation (NORT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2024to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of study entry.
- Written informed consent.
- Pathologically proven NSCLC irrespective of PD-L1 expression status.
- Tumor tissue is available for the mandatory translational research.
- Tumor stage T2b-3N0-1M0 according to the TNM classification, 8th edition.
- Tumor is considered resectable.
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- ECOG performance status 0-1.
- Adequate hematological values: hemoglobin ≥ 90 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L.
- Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN, AP ≤ 2.5 x ULN.
- Adequate renal function: calculated creatinine clearance ≥ 60 mL/min, according to the formula of Cockcroft-Gault.
- Women with child-bearing potential who are using effective contraception, are not pregnant or lactating and agree not to become pregnant during participation in the trial and during 90 days after the last treatment. A negative serum pregnancy test performed within 7 days before registration into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and during 90 days after the last treatment.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
Who cannot join
- Presence of any distant metastasis or N2 or N3 disease.
- Patients with a history of other malignancies, except non-active malignancy that does not require treatment, nor anticipated to require treatment for the duration of the study, and in the opinion of the investigator would not pose a risk of increased toxicity, or difficulty to follow the protocol and assess endpoints of the study.
- Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab.
- Absolute contraindications for the use of corticosteroids as premedication.
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to registration.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., which must not exceed 10 mg/day of prednisone or an equivalent corticosteroid).
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- Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's Correction.
- Body weight less than 30 kg.
- Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: - Vitiligo or resolved childhood asthma/atopy - Hypothyroidism stable on hormone replacement or Sjorgen's syndrome
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Known evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- History of primary immunodeficiency.
- History of allogeneic organ transplant.
- Receipt of live attenuated vaccination within 30 days prior to the first dose of durvalumab (COVID-19 vaccine is permitted).
- Any concomitant drugs contraindicated for use with durvalumab: this includes systemic corticosteroids, methotrexate, azathioprine, and tumor necrosis factor (TNF)-α blockers. Any concomitant drugs contraindicated for use with the other trial drugs according to the locally approved product information.
- Any other serious underlying medical (e.g., uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, severe hearing impairment), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Pre-sUrgical Plan in Locally Advanced Non-small Cell Lung Cancer Employing Radiation, Immuno-Oncology and Resection
The Window-of-Opportunity (WOO) Network is a collaboration among Ontario's doctors and scientists to conduct clinical trials in newly-diagnosed cancer patients before they have surgery with an initial focus on understanding how cancer drugs can impact the immune system.
There is often a waiting period of two to six weeks between when a patient first receives a cancer diagnosis and their scheduled surgery. This period provides a unique opportunity to study tumours before they are treated, allowing scientists to explore new ways to identify cancer, measure how cancer cells respond to treatment, and understand how therapies work. WOO Network trials include drugs or treatments that already have been tested in other clinical trials or are already approved by Health Canada.
Read more
The SuPERIOR trial is a WOO trial and it is designed for cohort of patients patients diagnosed with newly-diagnosed cancer patients with stage two or three non-small cell lung cancer.
The patients who are enrolled in this trial will received combination of Non-ablative oligofractionated radiation (NORT) which is a low dose of radiation and one dose of Durvalumab, an immunotherapy drug before their surgery.
- Being tested
- Durvalumab, Non-ablative oligofractionated radiation (NORT)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
one dose of durvalumab (750 mg IV)
Non-ablative oligofractionated radiation (NORT)Radiation
12 Gy of Radiation in 3 fractions
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant NORT-durvalumab | Experimental | administration of non-ablative oligofractionated radiation therapy using 12 Gy in 3 fractions in combination with one dose of durvalumab (750 mg IV) prior to surgery. Receives: Drug: Durvalumab; Radiation: Non-ablative oligofractionated radiation (NORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring CD8 TILs density post NORT-durvalumab
Neoadjuvant durvalumab in combination with non-ablative oligofractionated radiation therapy (NORT) using 12 Gy in 3 fractions can upregulate CD8+ tumor infiltrating lymphocytes (TILs) in T2b-3 N0-1 M0 non-small cell lung cancer (NSCLC)
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start28 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Why it stopped: Study Terminated Prior to trial activation, due to changes in SOC of the treatment
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 Cancer (NSCLC)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-centre, phase 2, WOO trial in patients with T2b-3N0-1M0 NSCLC evaluating the biologic efficacy of NORT-durvalumab administered prior to surgery. The trial will assess the feasibility of the study design using neoadjuvant NORT-durvalumab.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Marc de Perrot, MD, FRCSC, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191250
- Sponsor's protocol ID
- SuPERIOR
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Pre-sUrgical Plan in Locally Advanced Non-small Cell Lung Cancer Employing Radiation, Immuno-Oncology and Resection
- ClinicalTrials.gov ID
- NCT06191250
- Acronym / sponsor ID
- SuPERIOR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Terminated Prior to trial activation, due to changes in SOC of the treatment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (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 Window-of-Opportunity (WOO) Network is a collaboration among Ontario's doctors and scientists to conduct clinical trials in newly-diagnosed cancer patients before they have surgery with an initial focus on understanding how cancer drugs can impact the immune system.
There is often a waiting period of two to six weeks between when a patient first receives a cancer diagnosis and their scheduled surgery. This period provides a unique opportunity to study tumours before they are treated, allowing scientists to explore new ways to identify cancer, measure how cancer cells respond to treatment, and understand how therapies work. WOO Network trials include drugs or treatments that already have been tested in other clinical trials or are already approved by Health Canada.
The SuPERIOR trial is a WOO trial and it is designed for cohort of patients patients diagnosed with newly-diagnosed cancer patients with stage two or three non-small cell lung cancer.
The patients who are enrolled in this trial will received combination of Non-ablative oligofractionated radiation (NORT) which is a low dose of radiation and one dose of Durvalumab, an immunotherapy drug before their surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-centre, phase 2, WOO trial in patients with T2b-3N0-1M0 NSCLC evaluating the biologic efficacy of NORT-durvalumab administered prior to surgery. The trial will assess the feasibility of the study design using neoadjuvant NORT-durvalumab.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant NORT-durvalumab | Experimental | Drug: Durvalumab, Radiation: Non-ablative oligofractionated radiation (NORT)administration of non-ablative oligofractionated radiation therapy using 12 Gy in 3 fractions in combination with one dose of durvalumab (750 mg IV) prior to surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years at the time of study entry.
- Written informed consent.
- Pathologically proven NSCLC irrespective of PD-L1 expression status.
- Tumor tissue is available for the mandatory translational research.
- Tumor stage T2b-3N0-1M0 according to the TNM classification, 8th edition.
Key exclusion criteria (17 listed)
- Presence of any distant metastasis or N2 or N3 disease.
- Patients with a history of other malignancies, except non-active malignancy that does not require treatment, nor anticipated to require treatment for the duration of the study, and in the opinion of the investigator would not pose a risk of increased toxicity, or difficulty to follow the protocol and assess endpoints of the study.
- Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab.
- Absolute contraindications for the use of corticosteroids as premedication.
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to registration.
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 |
|---|---|---|
| Durvalumabone dose of durvalumab (750 mg IV) | Drug | Neoadjuvant NORT-durvalumab |
| Non-ablative oligofractionated radiation (NORT)12 Gy of Radiation in 3 fractions | Radiation | Neoadjuvant NORT-durvalumab |
Primary outcome
Measuring CD8 TILs density post NORT-durvalumab
Time frame: 17 days
Neoadjuvant durvalumab in combination with non-ablative oligofractionated radiation therapy (NORT) using 12 Gy in 3 fractions can upregulate CD8+ tumor infiltrating lymphocytes (TILs) in T2b-3 N0-1 M0 non-small cell lung cancer (NSCLC)
Results and safety
The study was stopped early (reason given: Study Terminated Prior to trial activation, due to changes in SOC of the treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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. This study is not recruiting at the moment.
Marc de Perrot, MD, FRCSC principal investigator
Toronto General Hospital
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 Durvalumab and Non-ablative oligofractionated radiation (NORT) in people with Non-Small Cell Lung Cancer (NSCLC) and Clinical Staging T2b-3 N0-1 M0, 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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 29 Jun 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.
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?
The study was stopped early (reason given: Study Terminated Prior to trial activation, due to changes in SOC of the treatment). Results are not available in the source record.
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?
Measuring CD8 TILs density post NORT-durvalumab (time frame: 17 days). 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 29 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.