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Monoclonal Antibodies
Nimotuzumab for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Grace Dy
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Summary
This trial is testing nimotuzumab and nivolumab, two drugs that help the immune system fight cancer. It targets patients with advanced non-small cell lung cancer that has spread and is hard to treat. These drugs work by helping the immune system recognize and attack cancer cells. Nivolumab is an immune checkpoint inhibitor that has shown promise in treating various cancers, including non-small cell lung cancer (NSCLC).
Eligible Conditions
- Non-Small Cell Lung Cancer
- Epidermal Growth Factor Receptor Mutations
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
DLT as graded by NCI CTCAE version 4.0 (Phase I)
ORR defined as complete response (CR) + partial response (PR) divided by number of patients as assessed by RECIST version 1.1 (Phase II)
Secondary study objectives
Incidence of adverse events assessed by NCI CTCAE version 4.0 (Phase I and II)
Other study objectives
EGFR expression in tumor tissue (Phase I and II)
PD-L1 expression in tumor tissue (Phase I and II)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, nimotuzumab)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 60 minutes and nimotuzumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nimotuzumab
2008
Completed Phase 3
~840
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,411 Total Patients Enrolled
Grace DyPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
256 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the ingredients in the study drugs or similar medicines.You have a heart problem that is not under control or you have trouble with your heart's function.You have a history of severe chest pain that cannot be controlled with medication.You are currently receiving any other cancer treatments besides nimotuzumab or nivolumab.You are expected to live for at least 3 more months.You have advanced lung cancer that has worsened after your first round of chemotherapy.You have a serious lung disease called interstitial lung disease (ILD).You currently have a serious infection that needs strong medication to treat it.You have been diagnosed with a heart condition called cardiomyopathy.You have brain metastases with symptoms, or uncontrolled fluid build-up around your lungs or heart.You have experienced severe heart inflammation or heart attack within the past year that did not get better with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, nimotuzumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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