RecruitingPhase 2NCT07016230

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)

Phase 2, Multicenter, Open Label, Platform 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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

40 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 (MTC, capped at 4 patients) 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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tarlatamab, an immune-activating drug, in patients with small cell lung cancer (SCLC) or other rare aggressive neuroendocrine cancers that have progressed after standard treatment, while also analyzing tumor biology to understand why some patients respond and others do not. **You may be eligible if...** - You are 18 or older with confirmed small cell lung cancer (any DLL3 level), or another rare high-grade neuroendocrine carcinoma that is DLL3-positive - Your cancer has progressed after at least one prior treatment including platinum-based chemotherapy - Your general health is adequate (ECOG 0, 1, or 2) - You are able and willing to provide tumor biopsy samples **You may NOT be eligible if...** - You have untreated brain metastases causing symptoms - Your organ function (heart, liver, kidneys) is significantly impaired - You are pregnant or breastfeeding - You are unable to tolerate the required study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarlatamab

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.


Locations(1)

Gustave Roussy

Villejuif, France

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NCT07016230