Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Drug: Tarlatamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06598306

20230298

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
• Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
• Participants must be able to have SC injections administered in the abdomen (and/or thigh).
• Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Exclusion criteria

• Participants that have received prior DLL3 targeted therapy.
• Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
• Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
• Participants with leptomeningeal disease.
• Participants with baseline oxygen requirement.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Part 1 Dose Exploration

Experimental group

Description:

Tarlatamab will be administered as a SC injection in Part 1.

Treatment:

Drug: Tarlatamab

Part 2 Dose Expansion

Experimental group

Description:

Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.

Treatment:

Drug: Tarlatamab