Recruiting
Phase 1
Phase 2

Panitumumab-IRDye800

Sponsor:

Stanford University

Code:

NCT03582124

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

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Near-Infrared Fluorescence Imaging

Panitumumab-IRDye800

Pharmacokinetic Study

Therapeutic Conventional Surgery

Study Details

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.

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 ID

NCT03582124

Start date

Jul 19, 2018

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Near-Infrared Fluorescence Imaging

Undergo imaging

Panitumumab-IRDye800

Given IV

Pharmacokinetic Study

Correlative studies

Therapeutic Conventional Surgery

Undergo surgery

Primary outcome measure

  • Tumor to background ratio (TBR), measured in ex vivo tissues [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Natalie Lui

650-721-2086natalielui@stanford.edu

Locations

Stanford University, School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Natalie Lui

650-721-2086natalielui@stanford.edu

Principal Investigator:

Natalie Lui

More Information

Sponsor

Stanford University

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-10.