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Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
IRDye800CW-nimotuzumab
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring IRDye800CW, Nimotuzumab, Lung cancer, EGFR, Near infrared, Image guided surgery, Optical imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Surgically resectable Stage I and II non-small cell lung cancer
  • Able to give informed consent
  • Age ≥ 18 and ≤ 80 years old
  • Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon
  • No prior history of malignancy
  • No neoadjuvant therapy
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
  • Hemoglobin (hgb) ≥ 90 g/L
  • White blood cell count (WBC) > 3 x 109/L
  • Platelet count (plt) ≥ 100 x 109/L
  • Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

  • Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug
  • Pregnant or nursing
  • Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Sites / Locations

  • St. Paul's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Low dose intermediate time

High dose intermediate time

Optimal dose early time

Optimal dose late time

Arm Description

Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Outcomes

Primary Outcome Measures

Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
To identify the dose with the highest tumor fluorescence and TBR.
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
To identify the imaging time with the highest tumor fluorescence and TBR.

Secondary Outcome Measures

Determine primary tumor margins.
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Identify EGFR positive lymph nodes.
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Safety of IRDye800CW-nimotuzumab
a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.

Full Information

First Posted
June 22, 2020
Last Updated
May 24, 2022
Sponsor
University of Saskatchewan
Collaborators
Western Economic Diversification Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04459065
Brief Title
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Official Title
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Western Economic Diversification Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
IRDye800CW, Nimotuzumab, Lung cancer, EGFR, Near infrared, Image guided surgery, Optical imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose intermediate time
Arm Type
Experimental
Arm Description
Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
Arm Title
High dose intermediate time
Arm Type
Experimental
Arm Description
Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
Arm Title
Optimal dose early time
Arm Type
Experimental
Arm Description
Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
Arm Title
Optimal dose late time
Arm Type
Experimental
Arm Description
Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
Intervention Type
Drug
Intervention Name(s)
IRDye800CW-nimotuzumab
Intervention Description
50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion
Primary Outcome Measure Information:
Title
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
Description
To identify the dose with the highest tumor fluorescence and TBR.
Time Frame
up to 14 days
Title
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
Description
To identify the imaging time with the highest tumor fluorescence and TBR.
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Determine primary tumor margins.
Description
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Time Frame
up to 14 days
Title
Identify EGFR positive lymph nodes.
Description
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Time Frame
up to 14 days
Title
Safety of IRDye800CW-nimotuzumab
Description
a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.
Time Frame
up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Surgically resectable Stage I and II non-small cell lung cancer Able to give informed consent Age ≥ 18 and ≤ 80 years old Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon No prior history of malignancy No neoadjuvant therapy Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2 Hemoglobin (hgb) ≥ 90 g/L White blood cell count (WBC) > 3 x 109/L Platelet count (plt) ≥ 100 x 109/L Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug Pregnant or nursing Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Geyer, PhD
Phone
306-966-12040
Email
ron.geyer@usask.ca
Facility Information:
Facility Name
St. Paul's Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 0Z9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Geyer, PhD
First Name & Middle Initial & Last Name & Degree
Humphrey Fonge, PhD
First Name & Middle Initial & Last Name & Degree
Kris Barreto, PhD
First Name & Middle Initial & Last Name & Degree
Wendy Bernhard, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

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