OncoMatch/Clinical Trials/NCT06893783
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Is NCT06893783 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tarlatamab for neuroendocrine carcinomas (nec).
Treatment: Tarlatamab — This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — first-line (except prostate cancer, where platinum may be later line)
Subject has progressed or recurred following 1 platinum-based regimen: documented first disease progression must be during or following first-line platinum-based systemic chemotherapy. For patients with prostate cancer, especially in cases with treatment-emergent neuroendocrine carcinoma, platinum-based chemotherapy will not need to be the first line therapy.
Cannot have received: tarlatamab
Prior therapy with tarlatamab
Cannot have received: DLL3 pathway inhibitor
Prior therapy with any selective inhibitor of the DLL3 pathway
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9 /L; Platelet count ≥ 100 x 10^9/L; Hemoglobin > 9 g/dL (90 g/L)
Kidney function
eGFR ≥ 30 mL/min/1.73 m^2 or creatinine clearance ≥ 30 mL/min
Liver function
AST and ALT < 3 x ULN (or <5 x ULN for subjects with liver involvement); total bilirubin <1.5 x ULN (<2 x ULN for subjects with liver involvement) (except participants with Gilbert syndrome who must have total bilirubin <3.0 mg/dL)
Cardiac function
Cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by ECHO or MUGA, and no clinically significant ECG findings
Adequate organ function, defined as follows: Hematological function: Absolute neutrophil count ≥ 1.5 x 10^9 /L Platelet count ≥ 100 x 10^9/L Hemoglobin > 9 g/dL (90 g/L); Coagulation function: PT/INR and PTT or aPTT ≤ 1.5 x ULN except for subjects undergoing new class anticoagulant therapy (eg, Edoxaban), stable dose for 2 weeks required prior to enrollment; Renal function: eGFR ≥ 30 mL/min/1.73 m^2 or creatinine clearance ≥ 30 mL/min; Hepatic function: AST and ALT < 3 x ULN (or <5 x ULN for subjects with liver involvement) total bilirubin <1.5 x ULN (<2 x ULN for subjects with liver involvement) (except participants with Gilbert syndrome who must have total bilirubin <3.0 mg/dL); Pulmonary function: no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (eg, PleurX) are allowed baseline oxygen saturation >90% on room air; Cardiac function: cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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