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RecruitingPhase 1

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of tarlatamab given as a shot under the skin and how well people tolerate it. It is for adults with small cell lung cancer that has spread widely and has grown or returned after platinum-based cancer treatment.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, or the legal adult age in your country if it is older, when you sign the consent form.
  • Have small cell lung cancer that has spread widely, confirmed by testing cells or tissue.
  • Your cancer must have grown or returned after at least one platinum-based cancer treatment.
  • If you were treated when the cancer was limited to a smaller area, you must also have received another treatment after it returned and spread widely.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have a heart, lungs, kidneys, and liver that work well enough.
  • Be able to receive shots under the skin of your belly.
  • If your cancer cannot be measured or no tumor tissue is available, you may still join with approval from Amgen’s medical monitor.

Who can't join

  • Have had treatment targeting DLL3, a protein on cancer cells.
  • Have cancer that has spread to the brain and is untreated, causes symptoms, or needs steroid treatment. Treated brain cancer spread without symptoms is allowed. Untreated spread without symptoms may be allowed with special approval if the study doctor says local treatment is not needed.
  • Have cancer that has spread to the tissue and fluid around the brain and spinal cord.
  • Need extra oxygen before starting the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. * 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.

Study sites (6)

CA

IL

MI

SD

TX

WA