Subcutaneous Tarlatamab for Advanced Small Cell Lung Cancer
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Recruiting
Phase 1Interventional Study
Extensive Stage Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
220 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for adults with advanced small cell lung cancer that has continued to progress after treatment. Participants will receive subcutaneous injections of tarlatamab and be monitored for safety and side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with extensive stage small cell lung cancer.
My cancer has progressed after at least one treatment with platinum-based therapy.
I have a good performance status (ECOG 0 or 1).
I have adequate organ function.
I can receive injections in my abdomen.
You may not be able to join if
I have received prior treatment specifically targeting DLL3.
I have untreated or symptomatic brain metastases.
I have leptomeningeal disease.
I need oxygen treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Trial Locations
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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-base…
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.
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