Extensive Stage Small Cell Lung CancerPhase 1NCT05361395
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
A Phase 1 study testing Tarlatamab, Carboplatin and Etoposide in people with Extensive Stage Small Cell Lung Cancer, run by Amgen at 44 sites in 15 countries.
Trial summary
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy. 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, Carboplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 44 sitesin 15 countries
- Study dates
- 24 Aug 2022to 30 May 2030
- Phase
- Phase 1
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
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age greater than or equal to 18 years old at the same time of signing the informed consent.
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
- Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
- Adequate organ function as defined in protocol.
Who cannot join
- History of other malignancy within the past 2 years with exceptions.
- Major surgery within 28 days of study day 1.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
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- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
- Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
- NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
- History of hypophysitis or pituitary dysfunction.
- History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
Trial locations and contacts
44 sites in 15 countries.
44 sites in 15 countries
United States9 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Henry Ford Health System
Detroit, Michigan, 48202
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
West Virginia University Health Sciences Center
Morgantown, West Virginia, 26506
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016
Christiana Care Health Services
Newark, Delaware, 19713
Swedish Cancer Institute Medical Oncology
Seattle, Washington, 98104
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Belgium4 sites
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
AZ Delta Campus Rumbeke
Roeselare, 8800
Israel4 sites
Rambam Medical Center
Haifa, 3109601
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 5265601
France3 sites
Centre Leon Berard
Lyon, 69373
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
Saint-Herblain, 44800
Gustave Roussy
Villejuif, 94805
Germany3 sites
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Essen
Essen, 45147
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Italy3 sites
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB), 20900
Istituto Nazionale Tumori Regina Elena
Rome, 00144
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Spain3 sites
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
Taiwan3 sites
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Canada2 sites
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, G1R 2J6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Japan2 sites
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Switzerland2 sites
Universitaetsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
About this study
Official title: A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Tarlatamab, Carboplatin, Etoposide, Atezolizumab, Durvalumab
- Keywords
- Extensive Stage Small Cell Lung Cancer, ES-SCLC, SCLC, Lung Cancer, AMG 757, Bi-Specific T-Cell Engager, BiTE, Inmunotherapy, Immunooncology, Inmuno-oncology, DLL3, Delta Like Protein 3
- Medical subject headings
- Lung Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Also called AMG 757
Tarlatamab will be administered as an intravenous (IV) infusion.
CarboplatinDrug
Carboplatin will be administered as an intravenous (IV) infusion.
EtoposideDrug
Etoposide will be administered as an intravenous (IV) infusion.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab will be administered as an intravenous (IV) infusion.
DurvalumabDrug
Durvalumab will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Exploration Combination Regimen 1 | Experimental | Tarlatamab+Atezolizumab+Carboplatin+Etoposide Receives: Drug: Tarlatamab; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab |
| Part 2: Dose Exploration Combination Regimen 2 | Experimental | Tarlatamab+Atezolizumab+Carboplatin+Etoposide Receives: Drug: Tarlatamab; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab |
| Part 3: Dose Exploration Combination Regimen 3 | Experimental | Tarlatamab+Atezolizumab+Carboplatin+Etoposide Receives: Drug: Tarlatamab; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab |
| Part 4: Dose Expansion | Experimental | Expansion of Part 1, Part 2, or Part 3 with Atezolizumab Receives: Drug: Tarlatamab; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab |
| Part 5: Dose Exploration Maintenance | Experimental | Tarlatamab+Atezolizumab Receives: Drug: Tarlatamab; Drug: Atezolizumab |
| Part 6: Dose Expansion Maintenance | Experimental | Expansion of Part 5 with Atezolizumab Receives: Drug: Tarlatamab; Drug: Atezolizumab |
| Part 7: Dose Expansion | Experimental | Expansion of Part 1, 2, or 3 with Durvalumab Receives: Drug: Tarlatamab; Drug: Carboplatin; Drug: Etoposide; Drug: Durvalumab |
| Part 8: Dose Expansion Maintenance | Experimental | Expansion of Part 5 with Durvalumab Receives: Drug: Tarlatamab; Drug: Durvalumab |
| Part 9: Dose Expansion Maintenance | Experimental | Expansion with Tarlatamab+Durvalumab Receives: Drug: Tarlatamab; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a Dose Limiting Toxicity (DLT)
Measured: 24 months
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Measured: 24 months
Number of Participants with Treatment-related Adverse Events
Measured: 24 months
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: 24 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Measured: 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Measured: 24 months
Secondary outcomes (6)
6-month Progression-free Survival (PFS)
Measured: 24 months
Objective Response (OR)
Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 24 months
Duration of Response (DOR)
Measured: 24 months
Disease Control Rate(DCR)
Measured: 24 months
Overall Survival (OS)
Measured: 24 months
Serum Concentration of Tarlatamab
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start24 Aug 2022
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
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
- NCT05361395
- Sponsor's protocol ID
- 20200469
- Other IDs
- 2024-511021-58
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2022
- Last updated
- 9 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
- Expanded access
- Available
Publications
Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.
PubMed 40934933