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

StatusCompleted
PhasePhase 2
Started2018-12-31
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-08-19
notable
Trial completed
2026-08-19
minor
Completion moved earlier: 2026-10-31 → 2025-12-02
Trial Details
NCT Number NCT03728361
Lead Sponsor Dwight Owen
Collaborators: Bristol-Myers Squibb
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 +4 more
Enrollment 55 participants
Start Date 2018-12-31
Primary Completion 2025-12-02 (estimated)
Study Completion 2025-12-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-18