First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

September 7, 2026 updated by: Amgen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse
  • Belgium
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, 9000
        • Algemeen Ziekenhuis Maria Middelares
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis - Campus Virga Jesse
      • Roeselare, Belgium, 8800
        • AZ Delta Campus Rumbeke
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec Hopital de l Enfant Jesus
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Saint-Herblain, France, 44800
        • Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
      • Villejuif, France, 94805
        • Gustave Roussy
  • Germany
      • Dresden, Germany, 01307
        • Universitaetsklinikum Dresden
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Freiburg im Breisgau, Germany, 79106
        • Universitaetsklinikum Freiburg
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Ein-Kerem Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Sheba medical center
  • Italy
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Universitaria Renato Dulbecco
      • Monza (MB), Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori
      • Rome, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Catalonia
      • Badalona, Catalonia, Spain, 08916
        • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitari Vall D Hebron
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitaetsspital Basel
      • Bern, Switzerland, 3010
        • Inselspital Bern
  • Taiwan
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California, Norris Comprehensive Cancer Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Services
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10016
        • New York University Grossman School of Medicine and New York University Langone Hospitals
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute Medical Oncology
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Dose Exploration Combination Regimen 1
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Names:
  • Tecentriq
Experimental: Part 2: Dose Exploration Combination Regimen 2
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Names:
  • Tecentriq
Experimental: Part 3: Dose Exploration Combination Regimen 3
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Names:
  • Tecentriq
Experimental: Part 4: Dose Expansion
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Names:
  • Tecentriq
Experimental: Part 5: Dose Exploration Maintenance
Tarlatamab+Atezolizumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Names:
  • Tecentriq
Experimental: Part 6: Dose Expansion Maintenance
Expansion of Part 5 with Atezolizumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Names:
  • Tecentriq
Experimental: Part 7: Dose Expansion
Expansion of Part 1, 2, or 3 with Durvalumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Experimental: Part 8: Dose Expansion Maintenance
Expansion of Part 5 with Durvalumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Experimental: Part 9: Dose Expansion Maintenance
Expansion with Tarlatamab+Durvalumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
Drug: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with a Dose Limiting Toxicity (DLT)
Time Frame: 24 months
24 months
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Time Frame: 24 months
24 months
Number of Participants with Treatment-related Adverse Events
Time Frame: 24 months
24 months
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame: 24 months
24 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Time Frame: 24 months
24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 24 months
24 months
6-month Progression-free Survival (PFS)
Time Frame: 24 months
24 months
Objective Response (OR)
Time Frame: 24 months
Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
24 months
Duration of Response (DOR)
Time Frame: 24 months
24 months
Disease Control Rate(DCR)
Time Frame: 24 months
24 months
Serum Concentration of Tarlatamab
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200469
  • 2024-511021-58 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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