Tarlatamab treatment for extensive stage small cell lung cancer

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)

This study is testing a new treatment called tarlatamab for people with extensive stage small cell lung cancer who haven't had success with previous chemotherapy to see if it helps them feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amgen (Industry-sponsored)
• Drugs / interventions: tarlatamab
• Locations: 30 sites (Los Angeles, California and 29 other locations)
• Trial ID: NCT06598306 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of subcutaneous tarlatamab in participants with extensive stage small cell lung cancer (ES-SCLC). The study involves administering tarlatamab to patients who have experienced disease progression after at least one line of platinum-based chemotherapy. Participants will be monitored for adverse effects and overall response to the treatment. The trial aims to gather data on the efficacy of this novel therapy in a challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed extensive stage small cell lung cancer who have progressed after prior platinum-based therapy.

Not a fit: Patients who have previously received DLL3 targeted therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with extensive stage small cell lung cancer.

How similar studies have performed: While this approach is novel, previous studies targeting DLL3 in small cell lung cancer have shown promise, indicating potential for success.

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.

Where this trial is running

Los Angeles, California and 29 other locations

• University of Southern California, Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
• University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
• Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor, Michigan, United States (Recruiting)
• Avera Cancer Institute — Sioux Falls, South Dakota, United States (Recruiting)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Swedish Cancer Institute — Seattle, Washington, United States (Recruiting)
• Chris OBrien Lifehouse — Camperdown, New South Wales, Australia (Recruiting)
• Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Universitair Ziekenhuis Gent — Ghent, Belgium (Recruiting)
• Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium (Recruiting)
• Centre Hospitalier Universitaire de Liege - Sart Tilman — Liège, Belgium (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Universitaetsklinikum Regensburg — Regensburg, Germany (Recruiting)
• Universitaetsklinikum Wuerzburg — Würzburg, Germany (Recruiting)
• Okayama University Hospital — Okayama, Okayama-ken, Japan (Recruiting)
• Wakayama Medical University Hospital — Wakayama, Japan (Recruiting)
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (Recruiting)
• Instytut Centrum Zdrowia Matki Polki — Lodz, Poland (Recruiting)
• Wojewodzki Szpital im Sw Ojca Pio w Przemyslu — Przemyśl, Poland (Recruiting)
• Hospital Regional Universitario de Malaga — Málaga, Andalusia, Spain (Recruiting)
• Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain (Recruiting)
• Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain (Recruiting)
• Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
• Kantonsspital Graubuenden — Chur, Switzerland (Recruiting)
• Freiburg Spital — Fribourg, Switzerland (Recruiting)
• Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
• Adana Sehir Egitim ve Arastirma Hastanesi — Adana, Turkey (Türkiye) (Recruiting)
• Ankara Bilkent Sehir Hastanesi — Ankara, Turkey (Türkiye) (Recruiting)
• Koc Universitesi Hastanesi — Istanbul, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Amgen Call Center

Conditions Extensive Stage Small Cell Lung Cancer; Small Cell Lung Cancer