Extensive Stage Small Cell Lung CancerPhase 1DeLLphi-311NCT07037758
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
A Phase 1 study testing Tarlatamab and AB248 in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 19 sites in 3 countries.
Trial summary
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248. The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- Tarlatamab and AB248
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 16 Sep 2025to 18 Jan 2031
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
- Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
- Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
- Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.
Who cannot join
- Symptomatic central nervous system (CNS) metastases.
- Participants with brain metastases may be eligible if criteria defined in the protocol are met.
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
- Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
- Baseline (at rest) requirement of supplemental oxygen.
Trial locations and contacts
19 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 3 countries
United States13 sites, 12 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Terminated
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202-1703
- Recruiting
Baptist Cancer Center
Memphis, Tennessee, 38120
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
- Recruiting
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
- Recruiting
Swedish Cancer Institute Medical Oncology
Seattle, Washington, 98109
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Siteman Cancer Center
St Louis, Missouri, 63110
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
South Korea3 sites, 3 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju Chungbuk, 28644
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370
- Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230
- Recruiting
Ankara Bilkent Sehir Hastanesi
Ankara, 06800
About this study
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Tarlatamab, AB248
- Keywords
- ES-SCLC, Tarlatamab, AMG 757, AB248, Imdelltra
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 as an IV infusion.
AB248Drug
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration | Experimental | Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion. Receives: Drug: Tarlatamab; Drug: AB248 |
| Dose Expansion | Experimental | The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part.
An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion. Receives: Drug: Tarlatamab; Drug: AB248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.
Measured: Up to 2.5 years
Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
Measured: Up to 35 days
Secondary outcomes (13)
Maximum Serum Concentration (Cmax) of Tarlatamab
Measured: Up to approximately 21 weeks
Minimum Serum Concentration (Cmin) of Tarlatamab
Measured: Up to approximately 21 weeks
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Measured: Up to approximately 21 weeks
Half-life (t1/2) of Tarlatamab
Measured: Up to approximately 21 weeks
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to 2.5 years
Duration of Response (DOR) per RECIST 1.1
Measured: Up to 2.5 years
Time to Response (TTR) per RECIST 1.1
Measured: Up to 2.5 years
Disease Control (DC) per RECIST 1.1
Measured: Up to 2.5 years
Progression-free Survival (PFS) per RECIST 1.1
Measured: Up to 2.5 years
Time to Progression (TTP) per RECIST 1.1
Measured: Up to 2.5 years
Time to Subsequent Therapy
Measured: Up to 2.5 years
Overall Survival (OS)
Measured: Up to 2.5 years
Number of Participants with Anti-AB248 Antibody Formation
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start16 Sep 2025
- Primary completion18 Mar 2028 (estimated)
- Study completion18 Jan 2031 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asher Biotherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037758
- Sponsor's protocol ID
- 20240200
- Acronym
- DeLLphi-311
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2025
- Last updated
- 25 Sep 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 25 Sep 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 Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
- ClinicalTrials.gov ID
- NCT07037758
- Acronym / sponsor ID
- DeLLphi-311 / 20240200
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- ES-SCLC, Tarlatamab, AMG 757, AB248, Imdelltra
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Asher Biotherapeutics, Inc.
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 18 Mar 2028 (estimated)
- Study completion
- 18 Jan 2031 (estimated)
- First posted
- 25 Jun 2025 (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 for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Exploration | Experimental | Drug: Tarlatamab, Drug: AB248Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion. |
| Dose Expansion | Experimental | Drug: Tarlatamab, Drug: AB248The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part. An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
- Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
- Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
Key exclusion criteria (5 listed)
- Symptomatic central nervous system (CNS) metastases.
- Participants with brain metastases may be eligible if criteria defined in the protocol are met.
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
- Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
- Baseline (at rest) requirement of supplemental oxygen.
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 as an IV infusion. | Drug | Dose Expansion, Dose Exploration |
| AB248Administered either as an IV infusion followed by a flush or using a syringe pump without a flush. | Drug | Dose Expansion, Dose Exploration |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2.5 years
Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.
Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Up to 35 days
13 secondary outcomes
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame: Up to approximately 21 weeks
Minimum Serum Concentration (Cmin) of Tarlatamab
Time frame: Up to approximately 21 weeks
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time frame: Up to approximately 21 weeks
Half-life (t1/2) of Tarlatamab
Time frame: Up to approximately 21 weeks
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 2.5 years
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to 2.5 years
Time to Response (TTR) per RECIST 1.1
Time frame: Up to 2.5 years
Disease Control (DC) per RECIST 1.1
Time frame: Up to 2.5 years
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to 2.5 years
Time to Progression (TTP) per RECIST 1.1
Time frame: Up to 2.5 years
Time to Subsequent Therapy
Time frame: Up to 2.5 years
Overall Survival (OS)
Time frame: Up to 2.5 years
Number of Participants with Anti-AB248 Antibody Formation
Time frame: Up to 2.5 years
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 25 Sep 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
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarlatamab and AB248 in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 19 sites in 3 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 6 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, South Korea, Turkey (Türkiye). 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 Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 2.5 years). The study lists 2 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 25 Sep 2026.