OncoMatch/Clinical Trials/NCT06893783
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Is NCT06893783 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Immunotherapy
Cancer type
Neuroendocrine Tumor
Pancreatic Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy — relapsed/refractory extra-pulmonary neuroendocrine carcinoma
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 ... platinum-based chemotherapy will not need to be the first line therapy.
Cannot have received: DLL3 pathway inhibitor (tarlatamab)
Prior therapy with tarlatamab
Cannot have received: DLL3 pathway inhibitor
Prior therapy with any selective inhibitor of the DLL3 pathway
Cannot have received: systemic therapy for EPNEC
Exception: In patients with treatment-emergent prostate neuroendocrine carcinoma, treatments given before histological confirmation of neuroendocrine cancer (e.g., androgen deprivation therapy, androgen receptor targeted agents such as enzalutamide and abiraterone, and docetaxel) are not considered as previous treatment for metastatic/recurrent EPNEC.
Subject received more than 2 prior systemic therapy regimens for EPNECs. In patients with treatment-emergent prostate neuroendocrine carcinoma, treatments given before histological confirmation of neuroendocrine cancer ... are not considered as previous treatment for metastatic/recurrent EPNEC.
Cannot have received: cardiotoxic drugs (e.g., anthracyclines)
Exception: Subjects who have not reached the limit dose are eligible
Subjects who have reached the limit dose of prior treatment with cardiotoxic drugs such as other anthracyclines
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Hemoglobin > 9 g/dL
Kidney function
eGFR ≥ 30 mL/min/1.73 m² 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 Gilbert syndrome: <3.0 mg/dL)
Cardiac function
Ejection fraction ≥50%, no clinically significant pericardial effusion, 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 ...; 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 ... are allowed baseline oxygen saturation >90% on room air; Cardiac function: cardiac ejection fraction ≥50%, no clinically significant pericardial effusion ... and no clinically significant ECG findings
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06893783 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior DLL3 pathway inhibitor, DLL3 pathway inhibitor, systemic therapy for EPNEC disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages