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

Stanford University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Stage IVA Lung Cancer AJCC v8

Stage IVB Lung Cancer AJCC v8

Lung Carcinoma

Metastatic Malignant Neoplasm in the Lung

Stage IV Lung Cancer AJCC v8

Treatments

Procedure: Therapeutic Conventional Surgery

Other: Pharmacokinetic Study

Procedure: Near-Infrared Fluorescence Imaging

Drug: Panitumumab-IRDye800

Study type

Interventional

Funder types

Other

Identifiers

NCT03582124

IRB-41302

NCI-2018-00494 (Registry Identifier)

LUN0099 (Other Identifier)

Details and patient eligibility

About

This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

Full description

PRIMARY OBJECTIVES:

I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.

II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.

OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.

Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.

After completion of study treatment, participants are followed up for up to 30 days.

Enrollment

30 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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