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

NCT03728361 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-12-18

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BIOLOGICAL

Nivolumab

Given IV

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

Principal Investigators

  • Dwight Owen, MD, MS · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2025-12-17
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728361 on ClinicalTrials.gov