OncoMatch/Clinical Trials/NCT07016230
Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance (UNLOCK TARLATAMAB)
Is NCT07016230 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Tarlatamab for metastatic/locally advanced small-cell lung cancer.
Treatment: Tarlatamab — UNLOCK TARLATAMAB is an open-label, single arm, multicenter, phase 2 platform study that aims to evaluate the mechanisms of action and resistance to tarlatamab in metastatic/locally advanced Small-Cell Lung Cancer (SCLC) with any level of DLL3 expression and in other poorly differentiated Neuroendocrine Carcinomas (NECs) DLL3 positive. The two cohorts of patients are the following: i. cohort 1: patients with SCLC with any level of DLL3 expression. ii. cohort 2: patients with other poorly differentiated NECs whatever the primary or high grade medullary thyroid carcinoma DLL3 positive by immunohistochemistry (IHC). Patients enrolled in both cohorts will receive treatment with tarlatamab at the dose of 1 mg on D1, 10 mg on D8 and D15 and Q2W thereafter in a 28-day cycle. Tarlatamab will be administrated in intravenous route until disease progression, unacceptable toxicity, or consent withdrawal. Tumor and blood samples will be collected at baseline, on-treatment and at progression in order to identify biomarkers of drug response
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Allowed: TP53 alteration
molecular alterations such as TP53, Rb1, and PTEN
Allowed: RB1 alteration
molecular alterations such as TP53, Rb1, and PTEN
Allowed: PTEN alteration
molecular alterations such as TP53, Rb1, and PTEN
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — SCLC or NEC
must have been treated with at least 1 line of prior therapy, including a platinum-based regimen (resistant or sensitive to platinum), have experienced progression on standard treatment
Must have received: androgen signaling inhibitor (abiraterone, enzalutamide, darolutamide, apalutamide) — treatment-emergent NEPC
an androgen signaling inhibitor (eg. abiraterone, enzalutamide, darolutamide and/or apalutamide) if treatment-emergent NEPC
Cannot have received: tarlatamab or any selective inhibitor of the DLL3 pathway
Prior treatment with tarlatamab or any selective inhibitor of the DLL3 pathway
Lab requirements
Blood counts
Platelet count ≥100,000/mm3; Hemoglobin ≥9.0 g/dL; ANC ≥1500/mm3
Kidney function
Creatinine clearance (CrCl) ≥30 mL/min
Liver function
AST/ALT and ALP <3 x ULN (or <5 x ULN for patients with liver metastases); total bilirubin <1.5 x ULN (<3 x ULN in Gilbert's Syndrome or <2 x ULN for patients with liver metastases)
Cardiac function
QTcF ≤470 ms (females), ≤450 ms (males); LVEF ≥50%; no recent MI or NYHA > class II; no significant pericardial effusion
adequate bone marrow reserve and organ function ... see full criterion 10; cardiac: Corrected QT interval >470 ms for females and >450 ms for males ... LVEF <50% ... Myocardial infarction within 6 months ... NYHA > class II within 6 months ... Clinically significant pericardial effusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07016230 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tarlatamab or any selective inhibitor of the DLL3 pathway 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