Small Cell Lung CancerPhase 1(DeLLphi-310)NCT06898957
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)
A Phase 1 study testing YL201, Tarlatamab and Durvalumab in people with Small Cell Lung Cancer, run by Amgen at 36 sites in 10 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1. 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?
- YL201, Tarlatamab and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 36 sitesin 10 countries
- Study dates
- 16 May 2025to 23 Jun 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
- Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
- Participants with histologically or cytologically confirmed ES-SCLC.
- For Parts 1 and 2, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC.
- For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without PD-(L)1 inhibitor in the first-line setting.
- At least 1 measurable lesion as defined by RECIST 1.1.
- Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).
Who cannot join
- Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
- Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
- Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Baseline requirement of supplemental oxygen.
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
United States11 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Yale New Haven Hospital
New Haven, Connecticut, 06510
Swedish Medical Center
Seattle, Washington, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, 54104
Siteman Cancer Center
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
France4 sites
Institut Bergonie
Bordeaux, 33000
Centre Leon Berard
Lyon, 69373
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
Gustave Roussy
Villejuif, 94805
Greece4 sites
Henry Dunant Hospital Center
Athens, 11526
Alexandra Hospital
Athens, 11528
European Interbalkan Medical Center
Thessaloniki, 57001
Iatriko Diavalkaniko Thessalonikis
Thessaloniki, 57001
Spain4 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
China3 sites
West China Hospital of Sichuan University
Chengdu, Sichuan, 611135
Fujian Cancer Hospital
Fuzhou, 350011
Shandong Cancer Hospital
Jinan, Shandong, 250117
Italy3 sites
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
Candiolo to, 10060
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), 47014
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Hungary2 sites
Semmelweis Egyetem
Budapest, 1083
Clinexpert Kft Bugat Pal Korhaz
Gyöngyös, 3200
About this study
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer
The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
- Conditions
- Small Cell Lung Cancer
- Being tested
- YL201, Tarlatamab, Durvalumab
- Keywords
- Small cell lung cancer, SCLC, Tarlatamab, YL201, Anti-PD-L1, Durvalumab
- 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.
YL201Drug
YL201 will be administered as an IV infusion.
TarlatamabDrug
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 YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing. Receives: Drug: YL201; Drug: Tarlatamab |
| Dose Expansion (Part 2) | Experimental | YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose. Receives: Drug: YL201; Drug: Tarlatamab |
| Triplet Combination (Part 3) | Experimental | YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) administered IV at a fixed dose. Receives: Drug: YL201; 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 Dose-limiting toxicities (DLTs)
Measured: Up to Day 21
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 3.5 Years
Secondary outcomes (12)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Up to 3.5 Years
Duration of Response (DOR) per RECIST 1.1
Measured: Up to 3.5 Years
Time to Response (TTR) per RECIST 1.1
Measured: Up to 3.5 Years
Disease Control Rate (DCR) per RECIST 1.1
Measured: Up to 3.5 Years
Progression-free Survival (PFS) per RECIST 1.1
Measured: Up to 3.5 Years
Time to Progression (TTP) per RECIST 1.1
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
Maximum Serum Concentration (Cmax) of Tarlatamab
Measured: Up to Week 36
Minimum Serum Concentration (Cmin) of Tarlatamab
Measured: Up to Week 36
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab
Measured: Up to Week 36
Half-life (t1/2) of Tarlatamab
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 posted27 Mar 2025
- Study start16 May 2025
- Primary completion23 Jun 2031 (estimated)
- Study completion23 Jun 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MediLink
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898957
- Sponsor's protocol ID
- 20240124
- Acronym
- (DeLLphi-310)
- Status last verified
- May 2026
- First submitted
- 21 Mar 2025
- Last updated
- 20 May 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 .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 20 May 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 YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06898957
- Acronym / sponsor ID
- (DeLLphi-310) / 20240124
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small cell lung cancer, SCLC, Tarlatamab, YL201, Anti-PD-L1, Durvalumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- MediLink
- Study start
- 16 May 2025 (actual)
- Primary completion
- 23 Jun 2031 (estimated)
- Study completion
- 23 Jun 2031 (estimated)
- First posted
- 27 Mar 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 of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
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: YL201, Drug: TarlatamabMultiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing. |
| Dose Expansion (Part 2) | Experimental | Drug: YL201, Drug: TarlatamabYL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose. |
| Triplet Combination (Part 3) | Experimental | Drug: YL201, Drug: Tarlatamab, Drug: DurvalumabYL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) administered IV at a fixed dose. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
- Participants with histologically or cytologically confirmed ES-SCLC.
- For Parts 1 and 2, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC.
- For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without PD-(L)1 inhibitor in the first-line setting.
- At least 1 measurable lesion as defined by RECIST 1.1.
Key exclusion criteria (5 listed)
- Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
- Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
- Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Baseline 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 |
|---|---|---|
| YL201YL201 will be administered as an IV infusion. | Drug | Dose Expansion (Part 2), Dose Exploration (Part 1), Triplet Combination (Part 3) |
| TarlatamabTarlatamab 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 Dose-limiting toxicities (DLTs)
Time frame: Up to Day 21
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 3.5 Years
12 secondary outcomes
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 3.5 Years
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to 3.5 Years
Time to Response (TTR) per RECIST 1.1
Time frame: Up to 3.5 Years
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to 3.5 Years
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to 3.5 Years
Time to Progression (TTP) per RECIST 1.1
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
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame: Up to Week 36
Minimum Serum Concentration (Cmin) of Tarlatamab
Time frame: Up to Week 36
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab
Time frame: Up to Week 36
Half-life (t1/2) of Tarlatamab
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 20 May 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 .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. This study is not recruiting at the moment.
MD study director
Amgen
36 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 YL201, Tarlatamab and Durvalumab in people with Small Cell Lung Cancer, run by Amgen at 36 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 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, France, Greece, Spain, China 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-limiting toxicities (DLTs) (time frame: Up to Day 21). 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 20 May 2026.