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RecruitingLast updated: 17 April 2026

DeLLphi-308: Injectable immunotherapy for the treatment of people with extensive stage small cell lung cancerA Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

DeLLphi-308

Clinical summary

Summary

The objective of this study is to evaluate how safe and tolerable injections of an immunotherapy called tarlatamab are in people with extensive stage small cell lung cancer. 

You may be eligible for this study if you have extensive stage small cell lung cancer (ES-SCLC) that has progressed or recurred following at least one line of platinumn-based anti-cancer therapy for SCLC.

The study has three parts.

  • Part 1 (Dose Exploration): Tarlatamab will be given as an injection into the skin (SC). Researchers will be looking to find the optimal dose level for further assessment.
  • Part 2 (Dose Expansion): The dosing regimen identified in Part 1 will be further tested in Part 2.
  • Part 3 (Alternative Dosing): Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2, Part 3 may be open to test alternative dosing of SC tarlatamab.

Conditions

This trial is treating people with extensive stage small cell lung cancer

Eligibility

Inclusion

  • 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.
  • 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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Amgen

Scientific Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

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