Lung CancerPhase 1/2NCT04459065
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
A Phase 1/2 study testing IRDye800CW-nimotuzumab in people with Lung Cancer, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- IRDye800CW-nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
Ronald Geyer, PhD
Humphrey Fonge, PhD
About this study
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.
- Conditions
- Lung Cancer
- Being tested
- IRDye800CW-nimotuzumab
- Keywords
- IRDye800CW, Nimotuzumab, Lung cancer, EGFR, Near infrared, Image guided surgery, Optical imaging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: IRDye800CW-nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
To identify the dose with the highest tumor fluorescence and TBR.
Measured: 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.
Measured: up to 14 days
Secondary outcomes (3)
Determine primary tumor margins.
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Measured: up to 14 days
Identify EGFR positive lymph nodes.
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Measured: up to 14 days
Safety of IRDye800CW-nimotuzumab
- 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.
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Sep 2020
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Western Economic Diversification Canada
- Responsible party
- Principal investigator, Steven Bharadwaj, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459065
- Sponsor's protocol ID
- CBIRD.20190430.Nimo800CW
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2020
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT04459065
- Acronym / sponsor ID
- CBIRD.20190430.Nimo800CW
- Conditions
- Lung Cancer
- Keywords
- IRDye800CW, Nimotuzumab, Lung cancer, EGFR, Near infrared, Image guided surgery, Optical imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Western Economic Diversification Canada
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
| Arm | Type | Receives |
|---|---|---|
| Low dose intermediate time | Experimental | Drug: IRDye800CW-nimotuzumabParticipants 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 |
| High dose intermediate time | Experimental | Drug: IRDye800CW-nimotuzumabParticipants 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 |
| Optimal dose early time | Experimental | Drug: IRDye800CW-nimotuzumabParticipants 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 |
| Optimal dose late time | Experimental | Drug: IRDye800CW-nimotuzumabParticipants 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRDye800CW-nimotuzumab50 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 | Drug | High dose intermediate time, Low dose intermediate time, Optimal dose early time, Optimal dose late time |
Primary outcome
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
Time frame: up to 14 days
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.
Time frame: up to 14 days
To identify the imaging time with the highest tumor fluorescence and TBR.
3 secondary outcomes
Determine primary tumor margins.
Time frame: up to 14 days
Identify EGFR positive lymph nodes.
Time frame: up to 14 days
Safety of IRDye800CW-nimotuzumab
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IRDye800CW-nimotuzumab in people with Lung Cancer, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ron Geyer, PhD (306-966-12040, ron.geyer@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery. (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.