A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
NCT ID: NCT05060016
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
222 participants
INTERVENTIONAL
2021-12-01
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] by investigator) of 2 dose levels of tarlatamab for Part 1 only
* evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2
* evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: Tarlatamab Low Dose
Participants will receive the low dose of Tarlatamab.
Tarlatamab
Intravenous (IV) infusion
Part 1: Tarlatamab High Dose
Participants will receive the high dose of Tarlatamab.
Tarlatamab
Intravenous (IV) infusion
Part 2: Dose Expansion
Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.
Tarlatamab
Intravenous (IV) infusion
Part 3: Modified Monitoring Substudy
Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.
Tarlatamab
Intravenous (IV) infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tarlatamab
Intravenous (IV) infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
* Histologically or cytologically confirmed relapsed/refractory SCLC
* Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy.
* Participants willing to provide archived tumor tissue samples or willing to undergo pretreatment tumor biopsy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 1.
* Minimum life expectancy of 12 weeks.
* Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab.
* Participants with treated brain metastases are eligible provided they meet defined criteria.
Exclusion Criteria
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Participants who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
* Unresolved toxicity from prior anti-tumor therapy, defined as per protocol.
Other Medical Conditions
* History of other malignancy within the past 2 years, with exceptions
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of tarlatamab.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
* Participant 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 tarlatamab.
* Presence of any indwelling line or drain.
* History of hypophysitis or pituitary dysfunction.
* Exclusion of hepatitis infection based on the results and/or criteria per protocol.
* Major surgery within 28 days of first dose of tarlatamab.
* History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Subject is eligible if no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of tarlatamab (counted from day of positive test for asymptomatic subjects).
Prior/Concomitant Therapy
* Participant received prior therapy with tarlatamab.
* Prior anti-cancer therapy within 28 days prior to first dose of tarlatamab.
* 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 tarlatamab.
* The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:
1. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study. Live viral non-replicating vaccine (e.g. Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines.
2. End of study treatment: Live and live-attenuated vaccines can be used when at least 42 days (5X half-life of tarlatamab) have passed after the last dose of tarlatamab.
Other Exclusions
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
* Female participants planning to become pregnant while on study through 60 days after the last dose of tarlatamab.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
* History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician.
Specific Exclusions to Part 3
* Participants unable to remain within one hour of study site for 48 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.
* Participants unable to remain within one hour of any hospital for 72 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.
* Unable to identify home companion who will cohabitate with participant for 72 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Christiana Care Health Services
Newark, Delaware, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Dana Farber - Harvard Cancer Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center
Hanover, New Hampshire, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States
Universitaetsklinikum Krems
Krems, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
Universitair Ziekenhuis Gent
Ghent, , Belgium
Grand Hopital de Charleroi - Site Saint Joseph
Gilly, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, , Belgium
Rigshospitalet
Copenhagen, , Denmark
Centre Hospitalier Universitaire Nord
Marseille, , France
Institut Curie
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Koeln
Cologne, , Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Henry Dunant Hospital Center
Athens, , Greece
Sotiria General Hospital
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
University Hospital of Heraklion
Heraklion - Crete, , Greece
General Hospital of Patras Agios Andreas
Pátrai, , Greece
Theagenion Cancer Hospital
Thessaloniki, , Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Agios Loukas Clinic
Thessaloniki, , Greece
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
Rome, , Italy
Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Centra Medyczne Medyceusz Sp zoo
Lodz, , Poland
Mazowieckie centrum leczenia
Otwock, , Poland
Hospital da Luz, SA
Lisbon, , Portugal
Hospital CUF Descobertas
Lisbon, , Portugal
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto, , Portugal
Hospital Cuf porto
Porto, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
National Cancer Centre Singapore
Singapore, , Singapore
National Cancer Center
Goyang-si Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Yonsei University Health System Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung medical center
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Instituto Catalan de Oncologia Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Sarah Cannon Research Institute UK
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Bustamante Alvarez J, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L; DeLLphi-301 Investigators. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 30;389(22):2063-2075. doi: 10.1056/NEJMoa2307980. Epub 2023 Oct 20.
Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.
Hummel HD, Ahn MJ, Blackhall F, Reck M, Akamatsu H, Ramalingam SS, Borghaei H, Johnson M, Dirnberger F, Cocks K, Huang S, Mukherjee S, Paz-Ares L. Patient-Reported Outcomes for Patients with Previously Treated Small Cell Lung Cancer Receiving Tarlatamab: Results from the DeLLphi-301 Phase 2 Trial. Adv Ther. 2025 Apr;42(4):1950-1964. doi: 10.1007/s12325-025-03136-4. Epub 2025 Mar 3.
Kong S, Minocha M, Chen PW, Martinez P, Anderson ES, Parkes A, Houk BE, Lin CW. Population Pharmacokinetics of Tarlatamab, a Half-Life Extended DLL3-Directed Bispecific T-Cell Engager in Patients with Previously Treated Small Cell Lung Cancer. Clin Pharmacokinet. 2025 May;64(5):729-741. doi: 10.1007/s40262-025-01499-z. Epub 2025 Apr 22.
Ahn MJ, Cho BC, Ohashi K, Izumi H, Lee JS, Han JY, Chiang CL, Huang S, Hamidi A, Mukherjee S, Xu KL, Akamatsu H. Asian Subgroup Analysis of Patients in the Phase 2 DeLLphi-301 Study of Tarlatamab for Previously Treated Small Cell Lung Cancer. Oncol Ther. 2025 Sep 4. doi: 10.1007/s40487-025-00372-0. Online ahead of print.
Chen PW, Minocha M, Kong S, Jiang T, Anderson ES, Parkers A, Martinez P, Houk BE, Lin CW. Tarlatamab exposure-efficacy and exposure-safety relationships to inform dose selection in patients with small cell lung cancer (SCLC). Clin Cancer Res. 2025 Sep 10. doi: 10.1158/1078-0432.CCR-25-2134. Online ahead of print.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511837-37
Identifier Type: OTHER
Identifier Source: secondary_id
20200491
Identifier Type: -
Identifier Source: org_study_id