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

Last updated: February 27, 2026
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Treatment

Durvalumab

Atezolizumab

Etoposide

Clinical Study ID

NCT05361395
20200469
2021-005462-17
2024-511021-58
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specificactivities/procedures.

  • Age greater than or equal to 18 years old at the same time of signing the informedconsent.

  • 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 theymeet defined criteria.

  • Adequate organ function as defined in protocol.

Exclusion

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 orlife-threatening immune-mediated adverse events or infusion-related reactionsincluding those that lead to permanent discontinuation while on treatment withimmuno-oncology agents.

  • History of immune-related colitis.

  • History or evidence of interstitial lung disease or active, non-infectiouspneumonitis.

  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or anyother form of immunosuppressive therapy within 7 days prior to the first dose ofstudy treatment.

  • Participants with symptoms and/or clinical signs and/or radiographic signs thatindicate an acute and/or uncontrolled active systemic infection within 7 days priorto the first dose of study treatment

  • Participant has known active infection requiring parenteral antibiotic treatment.Upon completion of parenteral antibiotics and resolution of symptoms, theparticipant may be considered eligible for the study from an infection standpoint

  • NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis arepermitted if responding to an active treatment and after consultation with MedicalMonitor. Participants requiring oral antibiotics who have been afebrile for >24hours, have no leukocytosis, nor clinical signs of infection are eligible. Screeningfor chronic infectious conditions is not required.

  • History of hypophysitis or pituitary dysfunction.

  • History of solid organ transplantation or allogeneic hematopoietic stem celltransplantation.

  • Active autoimmune disease that has required systemic treatment (except replacementtherapy) within the past 2 years or any other diseases requiring immunosuppressivetherapy while on study. Participants with Type I diabetes, vitiligo, psoriasis,hypo- or hyper-thyroid disease not requiring immunosuppressive treatment arepermitted.

Study Design

Total Participants: 184
Treatment Group(s): 5
Primary Treatment: Durvalumab
Phase: 1
Study Start date:
August 24, 2022
Estimated Completion Date:
August 28, 2028

Connect with a study center

  • Chris OBrien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Chris OBrien Lifehouse

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem 2799007, 2650
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Maria Middelares

    Gent, 9000
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Maria Middelares

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500
    Belgium

    Site Not Available

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt 2796491, 3500
    Belgium

    Site Not Available

  • AZ Delta Campus Rumbeke

    Roeselare, 8800
    Belgium

    Site Not Available

  • AZ Delta Campus Rumbeke

    Roeselare 2787889, 8800
    Belgium

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec 6325494, Quebec 6115047 G1R 2J6
    Canada

    Site Not Available

  • CHU de Quebec Hopital de l Enfant Jesus

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Site Not Available

  • Rigshospitalet

    Kobenhavn, 2100
    Denmark

    Site Not Available

  • Centre Leon Berard

    Lyon 2996944, 69373
    France

    Site Not Available

  • Centre Leon Berard

    Lyon cedex 8, 69373
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec

    Saint Herblain, 44800
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec

    Saint-Herblain 2979590, 44800
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Dresden

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau 2925177, 79106
    Germany

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Hadassah Ein-Kerem Medical Center

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva 293918, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan 293788, 5265601
    Israel

    Site Not Available

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, 88100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, 88100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro 2525059, 88100
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza (MB), 20900
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza (MB) 3172629, 20900
    Italy

    Site Not Available

  • IRCCS Istituti Fisioterapici Ospitalieri Istituto Nazionale Tumori Regina Elena

    Rome, 00144
    Italy

    Active - Recruiting

  • Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

    Rome, 00144
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Regina Elena

    Rome 3169070, 00144
    Italy

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 2113014 277-8577
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo 1850144 135-8550
    Japan

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen 2755251, 9713 GZ
    Netherlands

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona 3129028, Catalonia 3336901 08916
    Spain

    Site Not Available

  • Hospital Universitari Vall d Hebron

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Site Not Available

  • Institut Catala d Oncologia Badalona

    Badalona, Cataluña 08916
    Spain

    Active - Recruiting

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Cataluña 08916
    Spain

    Site Not Available

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Universitaetsspital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Universitaetsspital Basel

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern 2661552, 3010
    Switzerland

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan 1668355, 70403
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Christiana Care Health Services

    Newark, Delaware 19713
    United States

    Site Not Available

  • Christiana Care Health Services

    Newark 4143861, Delaware 4142224 19713
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    New York, New York 10016
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Site Not Available

  • Swedish Cancer Institute Medical Oncology

    Seattle, Washington 98104
    United States

    Site Not Available

  • Swedish Cancer Institute Medical Oncology

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • West Virginia University Health Sciences Center

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

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