Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntergroupe Francophone de Cancerologie Thoracique

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Standard of Care Chemotherapy
  • Tarlatamab

Treatment groups

129 Participants
are divided into 2 treatment groups