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New treatment option for Lung Cancer
Official title Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery
ClinicalTrials.gov ID: NCT04459065
What this study is testing
What is IRDye800CW-nimotuzumab?
IRDye800CW-nimotuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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...
- people receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- people with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
See the full eligibility 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
- 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
- people receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saskatoon, Saskatchewan, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.