Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

Launched by EBEN ROSENTHAL · Jun 27, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new method to help surgeons find cancer during lung surgery. It uses a special combination of a medicine called panitumumab and a dye called IRDye800, which can light up cancer cells when viewed with a special camera. The goal is to see if this combination can make it easier for doctors to spot and remove tumors in patients with lung cancer.

To be part of this trial, participants should have a lung nodule or mass that doctors suspect might be cancer and must be scheduled for surgery to remove it. They also need to be generally healthy enough to undergo surgery, with specific requirements for blood counts and kidney function. Participants can expect to receive the panitumumab-IRDye800 before surgery, and doctors will closely monitor how well it works in helping them detect cancer. This trial is currently recruiting participants and aims to improve cancer treatment outcomes by enhancing surgical visibility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
• • Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
• • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
• • Hemoglobin ≥ 9 gm/dL
• • White blood cell count \> 3000/mm\^3
• • Platelet count ≥ 100,000/mm\^3
• • Serum creatinine ≤ 1.5 times upper reference range
• Exclusion Criteria:
• • Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
• • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
• • History of infusion reactions to monoclonal antibody therapies
• • Pregnant or breastfeeding
• • Magnesium or potassium lower than the normal institutional values
• • Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
• • Prisoners, institutionalized individuals, and patients unable to consent for themselves