NCT04459065

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
5mo left

Started Sep 2020

Longer than P75 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2020Oct 2026

First Submitted

Initial submission to the registry

June 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

6 years

First QC Date

June 22, 2020

Last Update Submit

January 5, 2024

Conditions

Lung Cancer

Keywords

IRDye800CWNimotuzumabLung cancerEGFRNear infraredImage guided surgeryOptical imaging

Outcome Measures

Primary Outcomes (2)

  • Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.

    To identify the dose with the highest tumor fluorescence and TBR.

    up to 14 days

  • 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.

    up to 14 days

Secondary Outcomes (3)

  • Determine primary tumor margins.

    up to 14 days

  • Identify EGFR positive lymph nodes.

    up to 14 days

  • Safety of IRDye800CW-nimotuzumab

    up to 14 days

Study Arms (4)

Low dose intermediate time

EXPERIMENTAL

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

Drug: IRDye800CW-nimotuzumab

High dose intermediate time

EXPERIMENTAL

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

Drug: IRDye800CW-nimotuzumab

Optimal dose early time

EXPERIMENTAL

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

Drug: IRDye800CW-nimotuzumab

Optimal dose late time

EXPERIMENTAL

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

Drug: IRDye800CW-nimotuzumab

Interventions

IRDye800CW-nimotuzumabDRUG

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

High dose intermediate timeLow dose intermediate timeOptimal dose early timeOptimal dose late time

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ron Geyer, PhD

CONTACT

306-966-12040ron.geyer@usask.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thoracic surgeon

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 7, 2020

Study Start

September 1, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)