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Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection

Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer

NCT06331455•Marc de Perrot

View on ClinicalTrials.gov

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 before their surgery.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Age \> 18 years at time of study entry.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•4. Body weight \>30 kg
•5. 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:
•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)
+34 more criteria

Exclusion Criteria

•1. Participation in another clinical study with an investigational product during the last 8 weeks before enrollment
•2. 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
•3. Known oncogenic driver mutations such as EGFR mutant or ALK mutant
•4. The presence of N3 disease in the contralateral mediastinum, contralateral hilum, or contralateral supraclavicular lymph node confirmed histologically.

Locations (1)

Toronto General Hospital

Toronto, Canada

Key Dates

Start Date

May 22, 2024

Primary Completion Date

December 1, 2025

Completion Date

April 1, 2026

Last Updated

July 22, 2024

Enrollment

ESTIMATED participants

Conditions

Lung Cancer PatientsNon-small Cell Lung Cancer (NSCLC)

Interventions

Durvalumab

DRUG

Non-ablative oligofractionated radiation (NORT)

RADIATION

Contacts

Marc de Perrot, MD, FRCSC

CONTACT

4163405549 marc.deperrot@uhn.ca

Fatemeh Zaeimi, MSc

CONTACT

4163405686 fatemeh.zaeimi@uhn.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer