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

Trial Title: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT ID: NCT05060016

Condition: Relapsed/Refractory Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma

Conditions: Keywords:
Small Cell Lung Cancer
SCLC
AMG 757
Tarlatamab

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tarlatamab
Description: Intravenous (IV) infusion
Arm group label: Part 1: Tarlatamab High Dose
Arm group label: Part 1: Tarlatamab Low Dose
Arm group label: Part 2: Dose Expansion
Arm group label: Part 3: Modified Monitoring Substudy

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

Criteria for 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. - 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 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. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham

Address:
City: Birmingham
Zip: 35249
Country: United States

Facility:
Name: University of Arkansas for Medical Sciences

Address:
City: Little Rock
Zip: 72205
Country: United States

Facility:
Name: Christiana Care Health Services

Address:
City: Newark
Zip: 19713
Country: United States

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: Winship Cancer Institute

Address:
City: Atlanta
Zip: 30332
Country: United States

Facility:
Name: University of Iowa

Address:
City: Iowa City
Zip: 52242
Country: United States

Facility:
Name: Dana Farber - Harvard Cancer Center

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Henry Ford Health System

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Dartmouth Hitchcock Medical Center

Address:
City: Hanover
Zip: 03756
Country: United States

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27705
Country: United States

Facility:
Name: Wake Forest Baptist Comprehensive Cancer Research Center

Address:
City: Winston-Salem
Zip: 27157
Country: United States

Facility:
Name: Oncology Hematology Care Inc

Address:
City: Cincinnati
Zip: 45242
Country: United States

Facility:
Name: University Hospitals Cleveland Medical Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: University of Pittsburgh Medical Center Cancer Pavillion

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Facility:
Name: Sarah Cannon Research Institute

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: West Virginia University Health Sciences Center

Address:
City: Morgantown
Zip: 26506
Country: United States

Facility:
Name: Universitaetsklinikum Krems

Address:
City: Krems
Zip: 3500
Country: Austria

Facility:
Name: Landeskrankenhaus Salzburg

Address:
City: Salzburg
Zip: 5020
Country: Austria

Facility:
Name: Universitair Ziekenhuis Gent

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: Grand Hopital de Charleroi - Site Saint Joseph

Address:
City: Gilly
Zip: 6060
Country: Belgium

Facility:
Name: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: Rigshospitalet

Address:
City: Copenhagen
Zip: 2100
Country: Denmark

Facility:
Name: Centre Hospitalier Universitaire Nord

Address:
City: Marseille Cedex 20
Zip: 13915
Country: France

Facility:
Name: Institut Curie

Address:
City: Paris Cedex 05
Zip: 75248
Country: France

Facility:
Name: Centre Hospitalier Lyon Sud

Address:
City: Pierre-Benite cedex
Zip: 69495
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Address:
City: Rennes
Zip: 35033
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Address:
City: Strasbourg cedex
Zip: 67091
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Address:
City: Toulouse cedex 9
Zip: 31059
Country: France

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif
Zip: 94805
Country: France

Facility:
Name: LungenClinic Grosshansdorf GmbH

Address:
City: Grosshansdorf
Zip: 22927
Country: Germany

Facility:
Name: Universitaetsklinikum Koeln

Address:
City: Koeln
Zip: 50937
Country: Germany

Facility:
Name: Universitaetsklinikum Wuerzburg

Address:
City: Wuerzburg
Zip: 97078
Country: Germany

Facility:
Name: Henry Dunant Hospital Center

Address:
City: Athens
Zip: 11526
Country: Greece

Facility:
Name: Sotiria General Hospital

Address:
City: Athens
Zip: 11527
Country: Greece

Facility:
Name: Metropolitan Hospital

Address:
City: Athens
Zip: 18547
Country: Greece

Facility:
Name: University Hospital of Heraklion

Address:
City: Heraklion - Crete
Zip: 71500
Country: Greece

Facility:
Name: General Hospital of Patras Agios Andreas

Address:
City: Patra
Zip: 26335
Country: Greece

Facility:
Name: Theagenion Cancer Hospital

Address:
City: Thessaloniki
Zip: 54007
Country: Greece

Facility:
Name: Euromedica General Clinic of Thessaloniki

Address:
City: Thessaloniki
Zip: 54645
Country: Greece

Facility:
Name: Agios Loukas Clinic

Address:
City: Thessaloniki
Zip: 55236
Country: Greece

Facility:
Name: Azienda Ospedaliero-Universitaria di Parma

Address:
City: Parma
Zip: 43126
Country: Italy

Facility:
Name: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

Address:
City: Rome
Zip: 00144
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi

Address:
City: Varese
Zip: 21100
Country: Italy

Facility:
Name: Aichi Cancer Center

Address:
City: Nagoya-shi
Zip: 464-8681
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama-shi
Zip: 700-8558
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Osakasayama-shi
Zip: 589-8511
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Address:
City: Koto-ku
Zip: 135-8550
Country: Japan

Facility:
Name: Wakayama Medical University Hospital

Address:
City: Wakayama-shi
Zip: 641-8510
Country: Japan

Facility:
Name: National Cancer Center

Address:
City: Goyang-si Gyeonggi-do
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si, Gyeonggi-do
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Yonsei University Health System Severance Hospital

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung medical center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea Seoul St Marys Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Leids Universitair Medisch Centrum

Address:
City: Leiden
Zip: 2333 ZA
Country: Netherlands

Facility:
Name: Erasmus Medisch Centrum

Address:
City: Rotterdam
Zip: 3015 GD
Country: Netherlands

Facility:
Name: Uniwersyteckie Centrum Kliniczne

Address:
City: Gdansk
Zip: 80-214
Country: Poland

Facility:
Name: Centra Medyczne Medyceusz Sp zoo

Address:
City: Lodz
Zip: 91-053
Country: Poland

Facility:
Name: Mazowieckie centrum leczenia

Address:
City: Otwock
Zip: 05-400
Country: Poland

Facility:
Name: Hospital da Luz, SA

Address:
City: Lisboa
Zip: 1500-650
Country: Portugal

Facility:
Name: Hospital CUF Descobertas

Address:
City: Lisboa
Zip: 1998-018
Country: Portugal

Facility:
Name: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

Address:
City: Porto
Zip: 4099-001
Country: Portugal

Facility:
Name: Hospital Cuf porto

Address:
City: Porto
Zip: 4100-180
Country: Portugal

Facility:
Name: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Address:
City: Porto
Zip: 4200-072
Country: Portugal

Facility:
Name: National Cancer Centre Singapore

Address:
City: Singapore
Zip: 168583
Country: Singapore

Facility:
Name: Hospital Regional Universitario de Malaga

Address:
City: Malaga
Zip: 29011
Country: Spain

Facility:
Name: Hospital Universitari Vall d Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Clinic i Provincial de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital de la Santa Creu i Sant Pau

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Instituto Catalan de Oncologia Hospital Duran i Reynals

Address:
City: Hospitalet de Llobregat
Zip: 08908
Country: Spain

Facility:
Name: Hospital Universitari i Politecnic La Fe

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Hospital Universitario Puerta de Hierro Majadahonda

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hopitaux Universitaires de Geneve

Address:
City: Geneve 14
Zip: 1211
Country: Switzerland

Facility:
Name: Kaohsiung Chang Gung Memorial Hospital

Address:
City: Kaohsiung
Zip: 83301
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: Sarah Cannon Research Institute UK

Address:
City: London
Zip: W1G 6AD
Country: United Kingdom

Facility:
Name: Christie Hospital

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Start date: December 1, 2021

Completion date: October 31, 2026

Lead sponsor:
Agency: Amgen
Agency class: Industry

Source: Amgen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05060016
http://www.amgentrials.com