Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
Age ≥ 18 years.
WHO Performance status 0 - 1.
Well-differentiated neuroendocrine tumor (NET G1, G2 and G3 according to digestive WHO 2017 classification or typical/atypical carcinoid tumor according to lung WHO 2015 classification)
Previous treatment targeting DLL3
More than one line of systemic therapy in the metastatic setting. Chemotherapy for non-metastatic stage is not considered as first-line if there is a time interval of at least 6 months between the last dose of chemotherapy for non-metastatic stage and the initiation of first-line chemotherapy for metastatic/recurrent disease.
Small cell lung NEC (except as a minor <30% component in mixed tumors)
Parallel
Standard of Care Chemotherapy
DrugStudy treatment in the arm A is left to the investigator appreciations. This may include immune checkpoint inhibitors, docetaxel, topotecan for primary lung tumors, and FOLFOX, FOLFIRI or alkylating-based chemotherapy in primary digestive tumors.
Tarlatamab
DrugTarlatamab 10 mg every 2 weeks
Overall survival (OS) in patients who received at least one dose of treatment.
Time from date of inclusion to the date of death due to any cause. Time from date of inclusion to the date of death due to any cause. Time from date of inclusion to the date of death due to any cause.
Safety and tolerability of cemiplimab
Incidence, nature, and severity of treatment-related adverse events/treatment-emergent adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)except CRS and ICANS events graded using ASTCT 2019
Objective Response Rate (ORR)
Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)
Duration of Response (DoR)
Time from the date of the first response (CR or PR) to the earliest date of disease progression
Disease Control Rate (DCR)
Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)
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