Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMarc de Perrot
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Durvalumab
DrugTwo doses of durvalumab (1500 mg IV)
Non-ablative oligofractionated radiation (NORT)
Radiation12 Gy of Radiation in 3 fractions
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant NORT-DurvalumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To Measure CD8 TILs density & Major Pathological Response (MPR)
1. The proportion of patients achieving MPR after neoadjuvant therapy 2. The proportion of patients doubling the CD8 TILs density after neoadjuvant therapy.
Time frame
5-6 weeks post treatmentSecondary outcomes
1
To explore the efficacy and safety of NORT-durvalumab
1. The proportion of patients achieving pCR after neoadjuvant therapy 2. The proportion of patients with grade 3, 4 or 5 toxicity
Time frame
12 weeks post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Marc de Perrot
Lead sponsor
University Health Network, Toronto
Sponsor institution
Ozmosis Research Inc.
Collaborator
Source ClinicalTrials.gov