A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
- Conditions
- Relapsed/Refractory Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05060016
- Lead Sponsor
- Amgen
- Brief 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
* evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 222
- 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.
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.
- 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:
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Dose Expansion Tarlatamab Participants will receive the selected target dose of Tarlatamab based on findings in Part 1. Part 1: Tarlatamab High Dose Tarlatamab Participants will receive the high dose of Tarlatamab. Part 1: Tarlatamab Low Dose Tarlatamab Participants will receive the low dose of Tarlatamab. Part 3: Modified Monitoring Substudy Tarlatamab Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.
- Primary Outcome Measures
Name Time Method Part 1 and Part 3 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events Up to a maximum of 24 months Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Part 1 Only: Serum Concentrations of Tarlatamab Up to a maximum of 24 months Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) Up to a maximum of 24 months
- Secondary Outcome Measures
Name Time Method Serum Concentrations of Tarlatamab Up to a maximum of 24 months Overall Survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Number of Participants who Experience One or More Treatment-emergent Adverse Events Up to a maximum of 24 months Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) Up to a maximum of 24 months Progression-free Survival (PFS) Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) Up to a maximum of 24 months Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) Up to a maximum of 24 months Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) Up to a maximum of 24 months Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Up to a maximum of 24 months Number of Participants who Experience Anti-Tarlatamab Antibody Formation Up to a maximum of 24 months
Trial Locations
- Locations (80)
University of Pittsburgh Medical Center Cancer Pavillion
🇺🇸Pittsburgh, Pennsylvania, United States
Metropolitan Hospital
🇬🇷Athens, Greece
Agios Loukas Clinic
🇬🇷Thessaloniki, Greece
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Yonsei University Health System Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oncology Hematology Care Inc
🇺🇸Cincinnati, Ohio, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Universitaetsklinikum Krems
🇦🇹Krems, Austria
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Sotiria General Hospital
🇬🇷Athens, Greece
Okayama University Hospital
🇯🇵Okayama-shi, Okayama, Japan
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Mazowieckie centrum leczenia
🇵🇱Otwock, Poland
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
🇵🇹Porto, Portugal
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
West Virginia University Health Sciences Center
🇺🇸Morgantown, West Virginia, United States
Euromedica General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cancer Center
🇰🇷Goyang-si Gyeonggi-do, Korea, Republic of
University Hospital of Heraklion
🇬🇷Heraklion - Crete, Greece
Wakayama Medical University Hospital
🇯🇵Wakayama-shi, Wakayama, Japan
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Grand Hopital de Charleroi - Site Saint Joseph
🇧🇪Gilly, Belgium
Henry Dunant Hospital Center
🇬🇷Athens, Greece
Theagenion Cancer Hospital
🇬🇷Thessaloniki, Greece
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
Centra Medyczne Medyceusz Sp zoo
🇵🇱Lodz, Poland
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Dartmouth Hitchcock Medical Center
🇺🇸Hanover, New Hampshire, United States
Dana Farber - Harvard Cancer Center
🇺🇸Boston, Massachusetts, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Centre Hospitalier Universitaire Nord
🇫🇷Marseille Cedex 20, France
Institut Curie
🇫🇷Paris Cedex 05, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Benite cedex, France
Rigshospitalet
🇩🇰Copenhagen, Denmark
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
🇫🇷Strasbourg cedex, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
🇫🇷Rennes, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
🇫🇷Toulouse cedex 9, France
LungenClinic Grosshansdorf GmbH
🇩🇪Grosshansdorf, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Universitaetsklinikum Koeln
🇩🇪Koeln, Germany
General Hospital of Patras Agios Andreas
🇬🇷Patra, Greece
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
🇮🇹Rome, Italy
Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Samsung medical center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Hospital Cuf porto
🇵🇹Porto, Portugal
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Andalucía, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Instituto Catalan de Oncologia Hospital Duran i Reynals
🇪🇸Hospitalet de Llobregat, Cataluña, Spain
Hopitaux Universitaires de Geneve
🇨🇭Geneve 14, Switzerland
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Wake Forest Baptist Comprehensive Cancer Research Center
🇺🇸Winston-Salem, North Carolina, United States