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

NCT ID: NCT03582124

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2027-02-28

Brief Summary

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.

Detailed 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.

Conditions

Lung Carcinoma; Metastatic Malignant Neoplasm in the Lung; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (panitumumab-IRDye800, surgery, NIR)

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

Group Type: EXPERIMENTAL

Near-Infrared Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo imaging

Panitumumab-IRDye800

Intervention Type: DRUG

Given IV

Pharmacokinetic Study

Intervention Type: OTHER

Correlative studies

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Undergo surgery

Interventions

Near-Infrared Fluorescence Imaging

Undergo imaging

Intervention Type: PROCEDURE

Panitumumab-IRDye800

Given IV

Intervention Type: DRUG

Pharmacokinetic Study

Correlative studies

Intervention Type: OTHER

Therapeutic Conventional Surgery

Undergo surgery

Intervention Type: PROCEDURE

Other Intervention Names

NIR Fluorescence Imaging; NIR Optical Imaging; Panitumumab IRDye 800; RDye800-Panitumumab Conjugate; PHARMACOKINETIC; PK Study

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Lui

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Natalie Lui

Role: CONTACT

natalielui@stanford.edu

650-721-2086

Facility Contacts

Natalie Lui

Role: primary

natalielui@stanford.edu

650-721-2086

Other Identifiers

NCI-2018-00494

Identifier Type: REGISTRY

Identifier Source: secondary_id

LUN0099

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-41302

Identifier Type: -

Identifier Source: org_study_id