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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

Study Summary

This trial is studying nimotuzumab given with nivolumab to see how well they work in treating patients with non-small cell lung cancer.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Incidence of adverse events assessed by NCI CTCAE version 4.0 (Phase I and II)

Other outcome measures

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

~760

Nivolumab

2014

Completed Phase 3

~4750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,851 Total Patients Enrolled

Grace DyPrincipal InvestigatorRoswell Park Cancer Institute

2 Previous Clinical Trials

256 Total Patients Enrolled

Media Library

Nimotuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02947386 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Treatment (nivolumab, nimotuzumab)

Non-Small Cell Lung Cancer Clinical Trial 2023: Nimotuzumab Highlights & Side Effects. Trial Name: NCT02947386 — Phase 1

Nimotuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02947386 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Nimotuzumab an innocuous medication for individuals?

"Nimotuzumab has a score of 1 as it is still in Phase 1, indicating that there are only preliminary data attesting to its efficacy and safety."

Answered by AI

How many participants are involved in the research project?

"Unfortunately, no new patients are currently being accepted into this trial; its last update was on September 27th 2022. If you're still interested in clinical trials for egfr gene mutations and Nimotuzumab there are presently 1920 and 737 studies recruiting respectively."

Answered by AI

What medical purposes is Nimotuzumab commonly used for?

"Nimotuzumab is traditionally administered to combat metastatic ureter urothelial carcinoma, but it also has potential for treating malignant melanoma of skin, glioma and metastatic hepatocellular carcinoma."

Answered by AI

Is there any evidence to suggest that Nimotuzumab has been utilized in previous clinical trials?

"Presently, there are 737 active medical studies involving Nimotuzumab. Of these trials, 88 have reached Phase 3 of the research process. These scientific investigations originate from Zürich, BE and span 40354 locations worldwide."

Answered by AI

Are there any vacant slots available in this investigation?

"This clinical study is no longer recruiting patients. It was initially published on June 29th of 2017 and most recently updated on September 27th, 2022. Fortunately, there are many other trials looking for participants; 1920 studies related to EGFR gene mutations and 737 experiments regarding Nimotuzumab remain active."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nimotuzumab and Nivolumab in Treating Patients With Advanced Non-small Cell Lung Cancer

2017. "Nimotuzumab and Nivolumab in Treating Patients With Advanced Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02947386.