Lung Cancer Clinical Trial

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (DeLLphi-301)

Summary

The main aim of this study is to:

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
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:

Disease Related

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.
Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of 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.
Live and live-attenuated vaccines within 4 weeks prior to the start off tarlatamab treatment.

Other Exclusions

Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of tarlatamab.
Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab.
Female participants planning to become pregnant while on study through 72 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 132 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 132 days after the last dose of tarlatamab.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

192

Study ID:

NCT05060016

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 78 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Christiana Care Health Services
Newark Delaware, 19713, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute
Atlanta Georgia, 30332, United States
Dana Farber - Harvard Cancer Center
Boston Massachusetts, 02215, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Dartmouth Hitchcock Medical Center
Hanover New Hampshire, 03756, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem North Carolina, 27157, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
West Virginia University Health Sciences Center
Morgantown West Virginia, 26506, United States
Universitaetsklinikum Krems
Krems , 3500, Austria
Landeskrankenhaus Salzburg
Salzburg , 5020, Austria
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Grand Hopital de Charleroi - Site Saint Joseph
Gilly , 6060, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
Rigshospitalet
Copenhagen , 2100, Denmark
Centre Hospitalier Universitaire Nord
Marseille Cedex 20 , 13915, France
Institut Curie
Paris Cedex 05 , 75248, France
Centre Hospitalier Lyon Sud
Pierre-Benite cedex , 69495, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes , 35033, France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg cedex , 67091, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse cedex 9 , 31059, France
Institut Gustave Roussy
Villejuif , 94805, France
LungenClinic Grosshansdorf GmbH
Grosshansdorf , 22927, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , 97078, Germany
Henry Dunant Hospital Center
Athens , 11526, Greece
Sotiria General Hospital
Athens , 11527, Greece
Metropolitan Hospital
Athens , 18547, Greece
University Hospital of Heraklion
Heraklion - Crete , 71500, Greece
General Hospital of Patras Agios Andreas
Patra , 26335, Greece
Theagenion Cancer Hospital
Thessaloniki , 54007, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki , 54645, Greece
Agios Loukas Clinic
Thessaloniki , 55236, Greece
Azienda Ospedaliero-Universitaria di Parma
Parma , 43126, Italy
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
Rome , 00144, Italy
Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi
Varese , 21100, Italy
Aichi Cancer Center
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
Okayama University Hospital
Okayama-shi Okayama, 700-8, Japan
Kindai University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Wakayama Medical University Hospital
Wakayama-shi Wakayama, 641-8, Japan
National Cancer Center
Goyang-si Gyeonggi-do , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Yonsei University Health System Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung medical center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
Seoul , 06591, Korea, Republic of
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Centra Medyczne Medyceusz Sp zoo
Lodz , 91-05, Poland
Mazowieckie Centrum Leczenia
Otwock , 05-40, Poland
Hospital da Luz, SA
Lisboa , 1500-, Portugal
Hospital CUF Descobertas
Lisboa , 1998-, Portugal
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto , 4099-, Portugal
Hospital Cuf porto
Porto , 4100-, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto , 4200-, Portugal
National Cancer Centre Singapore
Singapore , 16961, Singapore
Hospital Regional Universitario de Malaga
Malaga Andalucía, 29011, Spain
Hospital Universitari Vall d Hebron
Barcelona Cataluña, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona Cataluña, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona Cataluña, 08041, Spain
Instituto Catalan de Oncologia Hospital Duran i Reynals
Hospitalet de Llobregat Cataluña, 08908, Spain
Hospital Universitari i Politecnic La Fe
Valencia Comunidad Valenciana, 46026, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hopitaux Universitaires de Geneve
Geneve 14 , 1211, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 83301, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom
Christie Hospital
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

192

Study ID:

NCT05060016

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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