Extensive Stage Small Cell Lung CancerPhase 1DeLLphi-308NCT06598306
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
A Phase 1 study testing Tarlatamab in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 31 sites in 10 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- Tarlatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 31 sitesin 10 countries
- Study dates
- 7 Oct 2024to 24 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 10 countries
United States6 sites, 6 recruiting
- Recruiting
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, 48106
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Australia3 sites, 3 recruiting
- Recruiting
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
Belgium3 sites, 3 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
- Recruiting
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000
Poland3 sites, 3 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
- Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
- Recruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Graubuenden
Chur, 7000
- Recruiting
Freiburg Spital
Fribourg, 1708
- Recruiting
Kantonsspital Winterthur
Winterthur, 8401
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370
- Recruiting
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
- Recruiting
Koc Universitesi Hastanesi
Istanbul, 34010
China2 sites, 2 recruiting
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Germany2 sites, 2 recruiting
- Recruiting
Universitaetsklinikum Regensburg
Regensburg, 93053
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97078
Japan2 sites, 2 recruiting
- Recruiting
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
- Recruiting
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
About this study
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)
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Tarlatamab
- Keywords
- Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Also called AMG 757, Imdelltra
Administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Exploration | Experimental | Tarlatamab will be administered as a SC injection in Part 1. Receives: Drug: Tarlatamab |
| Part 2 Dose Expansion | Experimental | Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1. Receives: Drug: Tarlatamab |
| Part 3 Alternative Dosing | Experimental | Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab. Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting toxicities (DLTs)
Measured: Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 24 months
Number of Participants with Changes in Vital Signs
Measured: Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Measured: Up to approximately 24 months
Secondary outcomes (12)
Maximum Serum Concentration (Cmax) of Tarlatamab
Measured: Up to approximately 12 months
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Measured: Up to approximately 12 months
Time to Cmax (Tmax) of Tarlatamab
Measured: Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Measured: Up to approximately 12 months
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to approximately 24 months
Duration of Response (DOR) per RECIST 1.1
Measured: Up to approximately 24 months
Time to Response (TTR) per RECIST 1.1
Measured: Up to approximately 24 months
Progression-free Survival (PFS) per RECIST 1.1
Measured: Up to approximately 24 months
Time to Progression per RECIST 1.1
Measured: Up to approximately 24 months
Time to Subsequent Therapy
Measured: Up to approximately 24 months
Overall Survival (OS)
Measured: Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Oct 2024
- Primary completion24 Apr 2027 (estimated)
- Study completion24 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598306
- Sponsor's protocol ID
- 20230298
- Acronym
- DeLLphi-308
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06598306
- Acronym / sponsor ID
- DeLLphi-308 / 20230298
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 24 Apr 2027 (estimated)
- Study completion
- 24 Apr 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Exploration | Experimental | Drug: TarlatamabTarlatamab will be administered as a SC injection in Part 1. |
| Part 2 Dose Expansion | Experimental | Drug: TarlatamabFollowing the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1. |
| Part 3 Alternative Dosing | Experimental | Drug: TarlatamabFollowing the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarlatamabAlso: AMG 757, ImdelltraAdministered by SC injection. | Drug | Part 1 Dose Exploration, Part 2 Dose Expansion, Part 3 Alternative Dosing |
Primary outcome
Number of Participants with Dose-limiting toxicities (DLTs)
Time frame: Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 24 months
Number of Participants with Changes in Vital Signs
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to approximately 24 months
12 secondary outcomes
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame: Up to approximately 12 months
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Time frame: Up to approximately 12 months
Time to Cmax (Tmax) of Tarlatamab
Time frame: Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time frame: Up to approximately 12 months
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to approximately 24 months
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Response (TTR) per RECIST 1.1
Time frame: Up to approximately 24 months
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Progression per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Subsequent Therapy
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
31 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarlatamab in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 31 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Spain, Australia, Belgium, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting toxicities (DLTs) (time frame: Up to day 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.