Small Cell Lung CancerPhase 3DeLLphi-315NCT07778316
Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)
A Phase 3 study testing Tarlatamab in people with Small Cell Lung Cancer, run by Amgen at 9 sites in 5 countries.
Trial summary
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- 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
- 400 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 28 Aug 2026to 30 Jul 2030
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
- Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
- Participants who progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
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- Minimum life expectancy of 12 weeks.
- Adequate organ function.
- History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.
Who cannot join
- Disease Related
- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.
- Other Medical Conditions
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
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- History of other malignancy within the past 2 years, with exceptions defined in the protocol.
- Presence or history of viral infection based on criteria per protocol.
- History of solid organ transplantation.
- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
- Known sensitivity or a contraindication to any of the products or components.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- Prior/Concomitant Therapy
- Prior systemic anticancer therapy within 30 days of enrolment
- Prior history of severe or life-threatening events from any immune-mediated therapy.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
- Live and live-attenuated vaccines within 28 days prior to the start of study treatment.
- Receiving another anticancer therapy for a malignancy other than SCLC.
- More than 1 prior line of anticancer therapy for SCLC.
- Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
- Treatment in an alternative investigational trial within 28 days prior to enrolment.
- History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.
- Other Exclusions
- Participants unable to have SC injections administered in the abdomen or thigh.
- Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
United States3 sites, 3 recruiting
- Recruiting
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
- Recruiting
Oncology Hematology West PC
Omaha, Nebraska, 68130
- Recruiting
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, 32806
China3 sites, 3 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Australia1 site, 1 recruiting
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Japan1 site, 1 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
Switzerland1 site, 1 recruiting
- Recruiting
Universitaetsspital Zuerich
Zurich, 8091
About this study
Official title: A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Tarlatamab
- Keywords
- Tarlatamab, ES-SCLC
- 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 via SC injection or IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Tarlatamab SC | Experimental | Participants will receive Tarlatamab via SC injection Receives: Drug: Tarlatamab |
| Tarlatamab IV | Active comparator | Participants will receive Tarlatamab via IV infusion Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Measured: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
Measured: On Cycle 2 Day 15 (each cycle is 28 days)
Secondary outcomes (11)
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Measured: Up to approximately 4 years
Progression free survival (PFS) per RECIST v1.1
Measured: Up to approximately 4 years
Duration of response (DOR) per RECIST v1.1
Measured: Up to approximately 4 years
Disease control (DC) per RECIST v1.1
Measured: Up to approximately 4 years
Overall survival (OS)
Measured: Up to approximately 4 years
Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Measured: Up to approximately 4 years
Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Measured: Up to approximately 4 years
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Measured: Up to approximately 4 years
Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Measured: Up to approximately 4 years
Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Measured: Up to approximately 4 years
Number of Participants with Anti-tarlatamab Antibody Formation
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start28 Aug 2026
- Primary completion24 Sep 2027 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778316
- Sponsor's protocol ID
- 20250046
- Acronym
- DeLLphi-315
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)
- ClinicalTrials.gov ID
- NCT07778316
- Acronym / sponsor ID
- DeLLphi-315 / 20250046
- Conditions
- Small Cell Lung Cancer
- Keywords
- Tarlatamab, ES-SCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 21 Aug 2026 (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 demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tarlatamab SC | Experimental | Drug: TarlatamabParticipants will receive Tarlatamab via SC injection |
| Tarlatamab IV | Active comparator | Drug: TarlatamabParticipants will receive Tarlatamab via IV infusion |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
- Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
- Participants who progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
Key exclusion criteria (26 listed)
- Disease Related
- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.
- Other Medical Conditions
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
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 via SC injection or IV infusion | Drug | Tarlatamab IV, Tarlatamab SC |
Primary outcome
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
Time frame: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
Time frame: On Cycle 2 Day 15 (each cycle is 28 days)
11 secondary outcomes
Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Time frame: Up to approximately 4 years
Progression free survival (PFS) per RECIST v1.1
Time frame: Up to approximately 4 years
Duration of response (DOR) per RECIST v1.1
Time frame: Up to approximately 4 years
Disease control (DC) per RECIST v1.1
Time frame: Up to approximately 4 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)
Time frame: Up to approximately 4 years
Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)
Time frame: Up to approximately 4 years
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Time frame: Up to approximately 4 years
Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother
Time frame: Up to approximately 4 years
Responses to Therapy Administration Satisfaction Questionnaire (TASQ)
Time frame: Up to approximately 4 years
Number of Participants with Anti-tarlatamab Antibody Formation
Time frame: Up to approximately 4 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 17 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
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tarlatamab in people with Small Cell Lung Cancer, run by Amgen at 9 sites in 5 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 9 inclusion and 26 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 17 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 9 sites in United States, China, Australia, Japan, Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab (time frame: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)). 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 17 Sep 2026.