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

NCT06598306

RecruitingPhase 1

Sponsor: Amgen

Conditions: Extensive Stage Small Cell Lung Cancer

Interventions: Tarlatamab

Countries: United States, Australia, Belgium, China, Germany, Japan, Poland, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (31)
  • Los Angeles, California, United States
  • Chicago, Illinois, United States
  • Ann Arbor, Michigan, United States
  • Sioux Falls, South Dakota, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Camperdown, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • Melbourne, Victoria, Australia
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Changchun, Jilin, China
  • Shanghai, Shanghai Municipality, China
  • Regensburg, Germany
  • Würzburg, Germany
  • Okayama, Okayama-ken, Japan
  • Wakayama, Wakayama, Japan
  • Gdansk, Poland
  • Lodz, Poland
  • Przemyśl, Poland
  • Málaga, Andalusia, Spain
  • Barcelona, Catalonia, Spain
  • Valencia, Valencia, Spain
  • Madrid, Spain
  • Chur, Switzerland
  • Fribourg, Switzerland
  • Winterthur, Switzerland
  • Adana, Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
  • + 1 more on CT.gov