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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT02947386
Phase
PHASE1
Status
Completed

Conditions

  • EGFR Gene Mutation
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nimotuzumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial studies the best dose and side effects of nimotuzumab when giving together with nivolumab and to see how well they work in treating patients with non-small cell lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as nimotuzumab and nivolumab, may block tumor growth in different ways by targeting certain cells.

Key Dates

Start date
Jun 29, 2017
Status verified
Oct 2023
Primary completion
Apr 15, 2021
Completion
Sep 8, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, nimotuzumab)
    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.

Primary Outcome Measure

DLT as graded by NCI CTCAE version 4.0 (Phase I) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NY

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