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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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:

• 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.

Locations
Other Locations
Canada
Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Marc de Perrot, MD, FRCSC
marc.deperrot@uhn.ca
4163405549
Backup
Fatemeh Zaeimi, MSc
fatemeh.zaeimi@uhn.ca
4163405686
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2026-04
Participants
Target number of participants: 12
Treatments
Experimental: Neoadjuvant NORT-Durvalumab
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.
Sponsors
Leads: Marc de Perrot
Collaborators: Ozmosis Research Inc.

This content was sourced from clinicaltrials.gov