Lung Cancer PatientsPhase 2SUPERNCT06331455
Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection
A Phase 2 study testing Durvalumab and Non-ablative oligofractionated radiation (NORT) in people with Lung Cancer Patients and Non-small Cell Lung Cancer (NSCLC), run by Marc de Perrot at 1 site in Canada.
Trial summary
The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery. Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Cancer Patients, Non-small Cell Lung Cancer (NSCLC)
- 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
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 22 May 2024to Apr 2026
- 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
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age > 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Body weight >30 kg
- Adequate normal organ and marrow function as defined below Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1.0 × 10^9/L Platelet count ≥75 × 10^9/L Serum bilirubin in normal range with the exception of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal
- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
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- Males:
- Creatinine CL (mL/min)=Weight (kg) x (140 - Age) / 72 x serum creatinine (mg/dL)
- Females:
- Creatinine CL (mL/min)=Weight (kg) x (140 - Age) x 0.85 / 72 x serum creatinine (mg/dL)
- 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.
- Must have a life expectancy of at least 12 weeks
- Tumor amenable to biopsy
- Patients with NSCLC stage IIB to IIIB.
- PD-L1 positive tumors defined by tumor proportion score (TPS) >1%
- Patient suitable for surgery and combined modality therapy in the opinion of the investigator.
- Complete R0 resection of the primary tumor and involved lymph nodes is anticipated based on the clinical staging and radiological evaluation according to the baseline pre-treatment imaging.
Who cannot join
- Participation in another clinical study with an investigational product during the last 8 weeks before enrollment
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Known oncogenic driver mutations such as EGFR mutant or ALK mutant
- The presence of N3 disease in the contralateral mediastinum, contralateral hilum, or contralateral supraclavicular lymph node confirmed histologically.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Sponsor.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the StudySponsor.
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- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the Study Sponsor Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another primary malignancy except for:
- Malignancy treated with curative intent 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 study endpoints Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease
- History of leptomeningeal carcinomatosis, malignant pleural effusion or distant metastasis (M1)
- Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
- History of active primary immunodeficiency
- Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
- Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE:
- Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto
Marc de Perrot, MD, 4163405549
Fatemeh Zaeimi, MSc, 4163405686
About this study
Official title: Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer
The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery.
Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles 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
Two doses of durvalumab (1500 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 two doses of durvalumab (1500 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.
To Measure CD8 TILs density & Major Pathological Response (MPR)
- The proportion of patients achieving MPR after neoadjuvant therapy
- The proportion of patients doubling the CD8 TILs density after neoadjuvant therapy.
Measured: 5-6 weeks post treatment
Secondary outcomes (1)
To explore the efficacy and safety of NORT-durvalumab
- The proportion of patients achieving pCR after neoadjuvant therapy
- The proportion of patients with grade 3, 4 or 5 toxicity
Measured: 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start22 May 2024
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PatientsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-centre, phase 2 trial in patients with T2b-3N0-1M0 NSCLC evaluating the biologic efficacy of NORT-Durvalumab administered prior to surgery.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc de Perrot
- Sponsor type
- University, hospital or other
- Collaborators
- Ozmosis Research Inc.
- Responsible party
- Sponsor-investigator, Marc de Perrot, University Health Network, Toronto
- Investigators
- Marc de Perrot, MD, FRCSC, Principal investigator, UHN - Toronto General Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331455
- Sponsor's protocol ID
- 23-5501
- Acronym
- SUPER
- Status last verified
- Jul 2024
- First submitted
- 19 Mar 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06331455
- Acronym / sponsor ID
- SUPER / 23-5501
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Marc de PerrotUniversity, hospital or other
- Collaborators
- Ozmosis Research Inc.
- Study start
- 22 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 26 Mar 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 SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery.
Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles 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 trial in patients with T2b-3N0-1M0 NSCLC evaluating the biologic efficacy of NORT-Durvalumab administered prior to surgery.
| 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 two doses of durvalumab (1500 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 (17 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age > 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Body weight >30 kg
- Adequate normal organ and marrow function as defined below Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1.0 × 10^9/L Platelet count ≥75 × 10^9/L Serum bilirubin in normal range with the exception of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal
Key exclusion criteria (32 listed)
- Participation in another clinical study with an investigational product during the last 8 weeks before enrollment
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Known oncogenic driver mutations such as EGFR mutant or ALK mutant
- The presence of N3 disease in the contralateral mediastinum, contralateral hilum, or contralateral supraclavicular lymph node confirmed histologically.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Sponsor.
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 |
|---|---|---|
| DurvalumabTwo doses of durvalumab (1500 mg IV) | Drug | Neoadjuvant NORT-Durvalumab |
| Non-ablative oligofractionated radiation (NORT)12 Gy of Radiation in 3 fractions | Radiation | Neoadjuvant NORT-Durvalumab |
Primary outcome
To Measure CD8 TILs density & Major Pathological Response (MPR)
Time frame: 5-6 weeks post treatment
1. The proportion of patients achieving MPR after neoadjuvant therapy 2. The proportion of patients doubling the CD8 TILs density after neoadjuvant therapy.
1 secondary outcome
To explore the efficacy and safety of NORT-durvalumab
Time frame: 12 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- 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
UHN - Toronto General Hopsital
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 Lung Cancer Patients and Non-small Cell Lung Cancer (NSCLC), run by Marc de Perrot 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 17 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc de Perrot, MD, FRCSC (4163405549, marc.deperrot@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure CD8 TILs density & Major Pathological Response (MPR) (time frame: 5-6 weeks 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 22 Jul 2024.