Nivolumab and Temozolomide in Treating Patients With Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroendocrine Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Dwight Owen
Study ID
NCT03728361
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Grade I Neuroendocrine Carcinoma
  • Grade II Neuroendocrine Carcinoma
  • Grade III Neuroendocrine Carcinoma
  • Large Cell Neuroendocrine Carcinoma
  • Lung Cancer Stage IV
  • Metastatic Neuroendocrine Carcinoma
  • Neuroendocrine Carcinoma
  • Neuroendocrine Tumors
  • Recurrent Small Cell Lung Carcinoma
  • Refractory Small Cell Lung Carcinoma
  • Small Cell Lung Cancer Metastatic
  • Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • Temozolomide — DRUG
    Given PO

Study Details

This phase II trial studies how well nivolumab and temozolomide work in treating patients with small-cell lung cancer that has come back or does not respond to treatment, or neuroendocrine cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and temozolomide may work better in treating patients with small-cell lung cancer and neuroendocrine cancer.

Key Dates

Start date
Dec 31, 2018
Status verified
Dec 2025
Primary completion
Dec 17, 2025
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Treatment (nivolumab, temozolomide)
    Patients receive nivolumab IV on day 1 of a 28 day cycle. Patients also receive temozolomide PO on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Up to 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer Center-COHORT 1ColumbusOhio43210-
Ohio State University Comprehensive Cancer Center-COHORT 2ColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Ohio State University Comprehensive Cancer Center-COHORT 1· Columbus, OHOhio State University Comprehensive Cancer Center-COHORT 2· Columbus, OH

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