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New treatment option for Extensive Stage Small Cell Lung Cancer
Official title Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
ClinicalTrials.gov ID: NCT06598306
What this study is testing
What is Tarlatamab?
Tarlatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for extensive stage small cell lung cancer.
Also referred to as AMG 757, Imdelltra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Participants with leptomeningeal disease.
- Participants with baseline oxygen requirement.
See the full eligibility 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...
- 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.
- 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...
- Participants with leptomeningeal disease.
- Participants with baseline oxygen requirement.
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.