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Recruiting NCT03582124

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

Phase I / Phase II Interventional Lung Carcinoma Metastatic Malignant Neoplasm in the Lung Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Near-Infrared Fluorescence Imaging, Panitumumab-IRDye800, Pharmacokinetic Study, Therapeutic Conventional Surgery.
Who it may be relevant to
Registry conditions: Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Near-Infrared Fluorescence Imaging
    Undergo imaging
  • Drug Panitumumab-IRDye800
    Given IV
  • Other Pharmacokinetic Study
    Correlative studies
  • Procedure Therapeutic Conventional Surgery
    Undergo surgery

Primary outcome measures

  • Tumor to background ratio (TBR), measured in ex vivo tissues [Time frame: Up to 1 year]
Secondary outcome measures (4)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Stanford University, School of Medicine — Palo Alto

Identifiers

NCT: NCT03582124 · IRB-41302 · NCI-2018-00494 · LUN0099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗