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

NCT03582124 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: IRB-41302NCI-2018-00494LUN0099
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 1 year

Secondary Outcomes (4)

• Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug

  Up to 30 days

• Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments

  Up to 1 year

• Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments

  Up to 1 year

• Residual disease detection by Panitumumab-IRDye800 versus standard assessments

  Up to 1 year

Study Arms (1)

Diagnostic (panitumumab-IRDye800, surgery, NIR)

EXPERIMENTAL

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

Procedure: Near-Infrared Fluorescence Imaging; Drug: Panitumumab-IRDye800; Other: Pharmacokinetic Study; Procedure: Therapeutic Conventional Surgery

Interventions

Near-Infrared Fluorescence Imaging PROCEDURE

Undergo imaging

Also known as: NIR Fluorescence Imaging, NIR Optical Imaging

Diagnostic (panitumumab-IRDye800, surgery, NIR)

Panitumumab-IRDye800 DRUG

Given IV

Also known as: Panitumumab IRDye 800, RDye800-Panitumumab Conjugate

Diagnostic (panitumumab-IRDye800, surgery, NIR)

Pharmacokinetic Study OTHER

Correlative studies

Also known as: PHARMACOKINETIC, PK Study

Diagnostic (panitumumab-IRDye800, surgery, NIR)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Diagnostic (panitumumab-IRDye800, surgery, NIR)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pharmacogenomic Variants

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Natalie Lui

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Lui

CONTACT

650-721-2086; natalielui@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 10, 2018
• Study Start: July 19, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)