NCT05060016PHASE2ACTIVE_NOT_RECRUITING

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

Sponsor: Amgen

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Relapsed/Refractory Small Cell Lung Cancer

Interventions

Tarlatamab

Enrollment

222 participants

Primary completion

Dec 2026

Study completion

Dec 2027

First posted

Sep 2021

Last updated

Dec 2025

Primary Endpoints (CT.gov)

Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

Time frame: Up to a maximum of 61 months

Part 1 and Part 3 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events

Time frame: Up to a maximum of 61 months

Part 1 Only: Serum Concentrations of Tarlatamab

Time frame: Up to a maximum of 24 months

Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

Time frame: Up to a maximum of 61 months

Secondary Endpoints

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

Eligibility Criteria

Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. * Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent. * Histologically or cytologically confirmed relapsed/refractory SCLC * Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy. * Participants willing to provide archived tumor tissue samples or willing to undergo pretreatment tumor biopsy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 1. * Minimum life expectancy of 12 weeks. * Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab. * Participants with treated brain metastases are eligible provided they meet defined criteria. Exclusion Criteria: Disease Related * Untreated or symptomatic brain metastases and leptomeningeal disease. * Has evidenc…

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov