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

No Placebo-Only Group

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
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

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010