Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
Extrapulmonary small cell carcinoma (EPSCC) or neuroendocrine carcinoma (NEC) is a rare but fatal disease. The prognosis of patients with advanced EPSCC or NEC failed platinum-etoposide chemotherapy is poor with median overall survival ranged 6 to 9 months. High expression levels of DLL3 has been demonstrated in many EPSCC or NEC. As tarlatamab, a bispecific T-cell engager with dual affinity for DLL3 on tumor cells and CD3 on T cells, has demonstrated clinically meaningful activity for patients with advanced small cell lung cancer. We thus hypothesize that tarlatamab also has clinically activity for patients with advanced EPSCC and NECs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent.
Failed prior platinum-based chemotherapy
Histologically proven extrapulmonary small cell carcinoma or neuroendocrine carcinoma from gastrointestinal tract, genitourinary tract, gynecologic origin, and head and neck or unknown primary. When mixed histology (ex, adenocarcinoma, squamous cell carcinoma or transitional carcinoma) is found, small cell carcinoma or neuroendocrine carcinoma should be the predominant part.
Measurable lesions by RECIST 1.1 within 28 days prior to the first dose of tarlatamab.
Disqualifiers
Uncontrolled brain metastasis and leptomeningeal disease.
Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Prior exposure to DLL3 targeting agent.
Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
Trial design
Design model
Single group
Treatments tested in this trial
Tarlatamab
DrugAll subjects will receive a step dose (1 mg tarlatamab) on cycle 1 day 1 administered as a 60-minute intravenous (IV) infusion then 10 mg tarlatamab IV administered on cycle 1 day 8, cycle 1 day 15, and every 2 weeks (Q2W) thereafter.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: TarlatamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) per RECIST 1.1 by investigator
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Amgen
Collaborator
Source ClinicalTrials.gov