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Nivolumab / Grade I Neuroendocrine Carcinoma / Temozolomide · Phase 2 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 2 trial registration with no posted results. The study enrolled 55 patients with recurrent or refractory small-cell lung cancer or advanced neuroendocrine cancer to receive nivolumab and temozolomide, with objective response rate by RECIST 1.1 as the primary endpoint. Clinical utility cannot be assessed from the registry record alone; outcome data must be consulted in peer-reviewed publications.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Grade I Neuroendocrine Carcinoma, Grade II Neuroendocrine Carcinoma, Grade III Neuroendocrine Carcinoma, Metastatic Neuroendocrine Carcinoma, Neuroendocrine Ca…; age from 18 Years. Intervention: Treatment (nivolumab, temozolomide). n = 55. 2 sites: United States.
This is a completed Phase 2 trial registration with no posted results. The study enrolled 55 patients with recurrent or refractory small-cell lung cancer or advanced neuroendocrine cancer to receive nivolumab and temozolomide, with objective response rate by RECIST 1.1 as the primary endpoint. Clinical utility cannot be assessed from the registry record alone; outcome data must be consulted in peer-reviewed publications.
No efficacy or safety results posted in this registry record.
This trial is not yet interpretable from the registry record. Clinicians and researchers should consult the published results to assess efficacy, safety, and any subgroup findings before considering this combination for patients with these aggressive cancers.
Phase 2 registry record with completed enrollment but no results posted; cannot assess efficacy or safety from registration alone.
As stated by the source record.
Quoted from the source exactly as published.
This trial is not yet interpretable from the registry record. Clinicians and researchers should consult the published results to assess efficacy, safety, and any subgroup findings before considering this combination for patients with these aggressive cancers.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03728361). This is a study registration, not published results. Lead sponsor: Dwight Owen. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 55 participants (ACTUAL). 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; DRUG: Temozolomide. Primary outcome measures: Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria , Up to 3 years. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.