Small Cell Lung CancerPhase 1DeLLphi-313NCT07531095
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
A Phase 1 study testing ZL-1310, Tarlatamab and Durvalumab in people with Small Cell Lung Cancer, run by Amgen at 27 sites in 9 countries.
Trial summary
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab. 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?
- ZL-1310, Tarlatamab and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 21 Apr 2026to 21 May 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 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 SCLC:
- For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
- For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
- For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.
- Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.
- Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).
Who cannot join
- Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
- History of interstitial lung disease (ILD)/pneumonitis.
- Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
- Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
- Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.
- Enrollment in any tarlatamab clinical trial.
Trial locations and contacts
27 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 9 countries
United States7 sites, 7 recruiting
- Recruiting
Next Virginia
Fairfax, Virginia, 22031
- Recruiting
City of Hope Cancer Center Phoenix
Goodyear, Arizona, 85338
- Recruiting
Baptist Cancer Center
Memphis, Tennessee, 38120
- Recruiting
New York University Cancer Institute
New York, New York, 10016
- Recruiting
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
City of Hope Chicago
Zion, Illinois, 60099
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Belgium3 sites, 3 recruiting
- Recruiting
Institut Jules Bordet
Brussels, B-1070
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
Ziekenhuis aan de Stroom Augustinus
Wilrijk, 2610
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel
Bron, 69677
- Recruiting
Hopital de la Timone
Marseille, 13005
- Recruiting
Gustave Roussy
Villejuif, 94805
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370
- Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230
- Recruiting
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575
Germany2 sites, 2 recruiting
- Recruiting
Universitaetsklinikum Dresden
Dresden, 01307
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97078
Poland2 sites, 2 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
- Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Gliwice, 44-102
Australia1 site, 1 recruiting
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
About this study
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
- Conditions
- Small Cell Lung Cancer
- Being tested
- ZL-1310, Tarlatamab, Durvalumab
- Keywords
- Tarlatamab, ZL-1310, Durvalumab, SCLC, Anti-PD-L1, Extensive Stage Small Cell Lung Cancer, Programmed death protein-1 (PD-1), Programmed death ligand 1 (PD-L1)
- 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.
ZL-1310Drug
ZL-1310 will be administered as an IV infusion.
TarlatamabDrug
Also called IMDELLTRA
Tarlatamab will be administered as an IV infusion.
DurvalumabDrug
Durvalumab will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration (Part 1) | Experimental | Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV). Receives: Drug: ZL-1310; Drug: Tarlatamab |
| Dose Expansion (Part 2) | Experimental | ZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV. Receives: Drug: ZL-1310; Drug: Tarlatamab |
| Triplet Combination (Part 3) | Experimental | ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV. Receives: Drug: ZL-1310; Drug: Tarlatamab; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Measured: Up to Day 21
Secondary outcomes (9)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Measured: Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Measured: Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Measured: Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Measured: Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Measured: Up to 3.5 years
Time to Subsequent Therapy
Measured: Up to 3.5 years
Overall survival (OS)
Measured: Up to 3.5 years
Serum Tarlatamab Concentrations
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start21 Apr 2026
- Primary completion21 May 2028 (estimated)
- Study completion21 May 2031 (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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT07531095
- Sponsor's protocol ID
- 20250114
- Other IDs
- 2025-522888-15-00, 2025
- Acronym
- DeLLphi-313
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Aug 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 21 Aug 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 ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07531095
- Acronym / sponsor ID
- DeLLphi-313 / 20250114
- Conditions
- Small Cell Lung Cancer
- Keywords
- Tarlatamab, ZL-1310, Durvalumab, SCLC, Anti-PD-L1, Extensive Stage Small Cell Lung Cancer, Programmed death protein-1 (PD-1), Programmed death ligand 1 (PD-L1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 21 May 2028 (estimated)
- Study completion
- 21 May 2031 (estimated)
- First posted
- 15 Apr 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 trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Exploration (Part 1) | Experimental | Drug: ZL-1310, Drug: TarlatamabMultiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV). |
| Dose Expansion (Part 2) | Experimental | Drug: ZL-1310, Drug: TarlatamabZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV. |
| Triplet Combination (Part 3) | Experimental | Drug: ZL-1310, Drug: Tarlatamab, Drug: DurvalumabZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 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 SCLC:
- For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
- For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
- For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.
Key exclusion criteria (7 listed)
- Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
- History of interstitial lung disease (ILD)/pneumonitis.
- Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
- Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
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 |
|---|---|---|
| ZL-1310ZL-1310 will be administered as an IV infusion. | Drug | Dose Expansion (Part 2), Dose Exploration (Part 1), Triplet Combination (Part 3) |
| TarlatamabAlso: IMDELLTRATarlatamab will be administered as an IV infusion. | Drug | Dose Expansion (Part 2), Dose Exploration (Part 1), Triplet Combination (Part 3) |
| DurvalumabDurvalumab will be administered as an IV infusion. | Drug | Triplet Combination (Part 3) |
Primary outcome
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: Up to Day 21
9 secondary outcomes
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Subsequent Therapy
Time frame: Up to 3.5 years
Overall survival (OS)
Time frame: Up to 3.5 years
Serum Tarlatamab Concentrations
Time frame: Up to Week 36
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 21 Aug 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
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZL-1310, Tarlatamab and Durvalumab in people with Small Cell Lung Cancer, run by Amgen at 27 sites in 9 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 7 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, Belgium, France, Turkey (Türkiye) and 4 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 Experiencing Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 3.5 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 21 Aug 2026.