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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)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Oct 18, 2026 → May 18, 2027
See other at-risk trials from Gustave Roussy, Cancer Campus, Grand Paris

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 18, 2026 to May 18, 2027
    • Enrollment reopened
    • Study sites: 1 to 3
    • Eligibility criteria shortened, about 75 words
    v5
  2. Enrollment closed, study ongoing
    • Primary completion moved earlier from Apr 15, 2027 to Oct 18, 2026
    • Site details revised
    v4
  3. Start date: Jun 24, 2025 to Jul 2, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2025 to Jun 24, 2025
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07016230
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: Amgen
Conditions
(from sponsor)		 Metastatic/Locally Advanced Small-Cell Lung Cancer, Metastatic/Locally Advanced Poorly Differentiated NEC
Related terms Neoplasm Metastasis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov