Tarlatamab treatment for extensive stage small cell lung cancer
Official title: 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)
Run by Amgen · NCT06598306 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | tarlatamab |
| Locations | 31 sites (Los Angeles, California and 30 other locations) |
| Status | Recruiting |
| Started | October 7, 2024 |
| Main results expected | April 24, 2027 |
| Study ends | April 24, 2030 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT06598306 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have previously received DLL3 targeted therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel, previous studies targeting DLL3 in small cell lung cancer have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 25 more locations
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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 -
Jilin Cancer Hospital
Changchun, Jilin, China 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, 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
- Email: medinfo@amgen.com
- Phone: 866-572-6436
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tarlatamab plus AB248 for extensive-stage small cell lung cancer (DeLLphi-311)
This trial tests whether combining tarlatamab with AB248 is safe and tolerable for adults whose extensive-stage small cell lung cancer has progressed after prior therapy.
-
Tarlatamab in strong-performance-status small-cell lung cancer
This trial tests whether tarlatamab can help people with extensive-stage small-cell lung cancer and poor health (ECOG 2) who have already had prior treatment.
-
QLC5508 plus QL2107 vs tislelizumab plus platinum chemotherapy as first treatment for extensive-stage small cell lung cancer
This phase 3 trial tests whether QLC5508 with QL2107 works better than tislelizumab with platinum chemotherapy for adults with untreated extensive-stage small cell lung cancer.
-
Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy
This trial tests whether subcutaneous tarlatamab works as well as the IV form for people with extensive-stage small cell lung cancer after platinum chemotherapy.
-
BL-M14D1 with Atezolizumab for extensive-stage small cell lung cancer
This phase 2 trial tests whether adding BL-M14D1 to atezolizumab helps people with extensive-stage small cell lung cancer live longer or well enough to continue treatment.
-
Tislelizumab use in European patients with NSCLC or ES-SCLC in routine care
This study looks at how tislelizumab is used in real-world European patients with advanced NSCLC or extensive-stage SCLC and what outcomes are seen in everyday clinical practice.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.