RecruitingInterventionalPhase 1/Phase 2

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures

NCT ID: NCT03582124Sponsor: Stanford UniversityLast updated: 2026-02-10

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.

Arms & interventions

ProcedureNear-Infrared Fluorescence Imaging
Undergo imaging
DrugPanitumumab-IRDye800
Given IV
OtherPharmacokinetic Study
Correlative studies
ProcedureTherapeutic Conventional Surgery
Undergo surgery

Outcome measures

Primary

Tumor to background ratio (TBR), measured in ex vivo tissues
The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery).
Time frame: Up to 1 year

Secondary

Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug
Time frame: Up to 30 days
Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
Time frame: Up to 1 year
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
Time frame: Up to 1 year
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
Time frame: Up to 1 year

Eligibility criteria

Sex: AllAge: 19 Years and olderHealthy volunteers: No

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

Study locations (1)

Stanford University, School of Medicine

Palo Alto, California, 94304

Recruiting

Natalie Lui · Contact

650-721-2086 natalielui@stanford.edu

Natalie Lui · Principal Investigator