NCT03728361

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

Active, enrolled Phase 2 Last updated 18 December 2025

What this trial tests

Phase 2 trial testing Nivolumab in Grade I Neuroendocrine Carcinoma in 55 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 December 2018

Primary endpoint
17 December 2025

31 October 2026

Quick facts

Lead sponsor	Dwight Owen
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	31 December 2018
Primary completion	17 December 2025
Estimated completion	31 October 2026
Sites	2 locations across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• Grade I Neuroendocrine Carcinoma — all drugs for Grade I Neuroendocrine Carcinoma →
• Grade II Neuroendocrine Carcinoma — all drugs for Grade II Neuroendocrine Carcinoma →
• Grade III Neuroendocrine Carcinoma — all drugs for Grade III Neuroendocrine Carcinoma →
• Metastatic Neuroendocrine Carcinoma — all drugs for Metastatic Neuroendocrine Carcinoma →

Sponsor

Dwight Owen — full company profile →

Who can join

18 and older, any sex, with Grade I Neuroendocrine Carcinoma or Grade II Neuroendocrine Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
2. Large Cell Neuroendocrine Carcinoma of the Lung: Current Understanding and Challenges.
   Andrini E, Marchese PV, De Biase D, Mosconi C, et al · · 2022 · cited 53× · PMID 35268551 · DOI 10.3390/jcm11051461
3. "Present and future of immunotherapy in Neuroendocrine Tumors".
   Albertelli M, Dotto A, Nista F, Veresani A, et al · · 2021 · cited 36× · PMID 33851319 · DOI 10.1007/s11154-021-09647-z
4. Expanding Therapeutic Opportunities for Extrapulmonary Neuroendocrine Carcinoma.
   Frizziero M, Kilgour E, Simpson KL, Rothwell DG, et al · · 2022 · cited 30× · PMID 35091446 · DOI 10.1158/1078-0432.ccr-21-3058
5. Landscape and Future Perspectives of Immunotherapy in Neuroendocrine Neoplasia.
   Maggio I, Manuzzi L, Lamberti G, Ricci AD, et al · · 2020 · cited 30× · PMID 32235636 · DOI 10.3390/cancers12040832
6. A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms.
   Owen DH, Benner B, Wei L, Sukrithan V, et al · · 2023 · cited 25× · PMID 36255391 · DOI 10.1158/1078-0432.ccr-22-1552
7. Immune Checkpoint Markers in Neuroendocrine Carcinoma of the Digestive System.
   Xing J, Ying H, Li J, Gao Y, et al · · 2020 · cited 24× · PMID 32181153 · DOI 10.3389/fonc.2020.00132
8. The recent progress of myeloid-derived suppressor cell and its targeted therapies in cancers.
   Ren R, Xiong C, Ma R, Wang Y, et al · · 2023 · cited 19× · PMID 37547175 · DOI 10.1002/mco2.323