IRDye800CW-nimotuzumab for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lung CancerIRDye800CW-nimotuzumab - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to image tumors during surgery, which may help surgeons better identify and remove cancer cells.

Eligible Conditions
  • Lung Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: up to 14 days

up to 14 days
Determine primary tumor margins.
Identify EGFR positive lymph nodes.
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
Safety of IRDye800CW-nimotuzumab

Trial Safety

Trial Design

4 Treatment Groups

Low dose intermediate time
1 of 4
Optimal dose early time
1 of 4
Optimal dose late time
1 of 4
High dose intermediate time
1 of 4

Experimental Treatment

36 Total Participants · 4 Treatment Groups

Primary Treatment: IRDye800CW-nimotuzumab · No Placebo Group · Phase 1 & 2

Low dose intermediate time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: Drug
Optimal dose early time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: Drug
Optimal dose late time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: Drug
High dose intermediate time
Drug
Experimental Group · 1 Intervention: IRDye800CW-nimotuzumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 days

Who is running the clinical trial?

University of SaskatchewanLead Sponsor
237 Previous Clinical Trials
90,279 Total Patients Enrolled
Western Economic Diversification CanadaOTHER_GOV
1 Previous Clinical Trials

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person has a Karnofsky performance status of at least 70% or an Eastern Cooperative Oncology Group (ECOG)/Zubrod level of 0-2.
The patient has enough reserve in their heart and lungs to undergo surgery to remove a section of their lung
(NSCLC) is the disease that can be cured by surgical resection
People aged between 18 and 80 years old.
You have a white blood cell count (WBC) > 3 x 109/L.
The platelet count is ≥ 100 x 109/L.