Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS) (NCT06816394) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)
Taiwan32 participantsStarted 2025-05-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. ECOG Performance Status (PS) of 0 or 1.
✓. Age greater or equal to 18 years old.
✓. Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \[FFPE\] sample) or willing to undergo pretreatment tumor biopsy.
✓. Subjects with treated brain metastases are eligible provided they meet the following criteria:
Exclusion criteria
What they're measuring
1
Objective response rate (ORR) per RECIST 1.1 by investigator
Timeframe: From enrollment to the end of treatment at 8 weeks
. 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.
✕. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \> 21 day) which may be allowed.
✕. History of other malignancy within the past 2 years, with the following exceptions:
✕. malignancy treated with curative intent and with no known active disease present for \> 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
✕. adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.