Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC) Clinical Trial

— DeLLphi-304  

Official title:

A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740566
• Other study ID #: 20210004
• Status: Recruiting
• Phase: Phase 3
• Start date: May 31, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age = 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
• Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
• Participants who progressed or recurred following 1 platinum-based regimen.
• Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function.

Exclusion Criteria:

• Disease Related
• Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
• Diagnosis or evidence of leptomeningeal disease.
• Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
• Other Medical Conditions
• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
• History of solid organ transplantation.
• History of other malignancy within the past 2 years, with exceptions defined in the protocol.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
• Presence or history of viral infection based on criteria per protocol.
• Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
• Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
• Evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Prior/Concomitant Therapy
• Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
• Prior therapy with any selective inhibitor of the DLL3 pathway.
• Participant received more than one prior systemic therapy regimen for SCLC.
• Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
• Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
• Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
• Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
• Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
• Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
• Major surgical procedures within 28 days prior to first dose of study treatment.
• Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
• Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Diagnostic Assessments
• Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, with exceptions defined in the protocol.
• 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 or donate eggs 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 by a 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.
• Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
• Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
• Participant has known sensitivity or is contraindicated 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 that would pose a risk to the subject safety or interfere with the study evaluation.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer (SCLC)
• Small Cell Lung Carcinoma

Intervention

Drug:
• Tarlatamab
Tarlatamab will be administered as an IV infusion.
• Lurbinectedin
Lurbinectedin will be administered per local SOC.
• Topotecan
Topotecan will be administered per local SOC.
• Amrubicin
Amrubicin will be administered per local SOC.

Locations

Country	Name	City	State
Argentina	Instituto Argentino de Diagnostico y Tratamiento IADT	Buenos Aires
Argentina	Cemic	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Sanatorio Allende	Córdoba
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Sanatorio Parque SA	Rosario	Santa Fe
Argentina	Clinica Viedma	Viedma	Río Negro
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Calvary Mater Newcastle Hospital	Waratah	New South Wales
Austria	Medizinische Universitaet Graz	Graz
Austria	Universitaetsklinikum Krems	Krems
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Jessa Ziekenhuis - Campus Virga Jesse	Hasselt
Belgium	AZ Delta Campus Rumbeke	Roeselare
Belgium	Vitaz campus Sint-Niklaas Moerland	Sint-Niklaas
Brazil	Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda	Ijui	Rio Grande Do Sul
Brazil	Liga Norte-Riograndense Contra O Cancer	Natal	Rio Grande Do Norte
Brazil	Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Amor da Amazonia	Porto Velho	Rondônia
Brazil	Instituto Coi	Rio de Janeiro
Brazil	Hospital Santa Izabel	Salvador	Bahia
Brazil	Instituto de Ensino e Pesquisa do Hospital da Bahia	Salvador	Bahia
Brazil	Hospital de Base de Sao Jose do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Beneficencia Portuguesa de Sao Paulo	Sao Paulo	São Paulo
Brazil	Oncologia Rede D Or	Sao Paulo	São Paulo
Brazil	Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp	São Paulo
Canada	London Health Sciences Centre	London	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chest Hospital, Capital Medical University	Beijing
China	Beijing Tongren Hospital affiliated to Capital Medical University	Beijing	Beijing
China	Army Special Medical Center of Peoples Liberation Army	Chongqing	Chongqing
China	The Second Affiliated Hospital of Army Medical University, PLA	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Affiliated Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Anhui Chest Hospital	Hefei	Anhui
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Tumor Hospital	Jinan	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanxi Province Cancer Hospital	Taiyuan	Shanxi
China	Taizhou Peoples Hospital	Taizhou	Zhejiang
China	Tianjin Peoples Hospital	Tianjin
China	Weihai Municipal Hospital	Weihai
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Subei Peoples Hospital	Yangzhou	Jiangsu
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Nemocnice Agel Ostrava-Vitkovice as	Ostrava-Vitkovice
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon	Grenoble
France	Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon	Lille Cedex
France	Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren	Limoges Cedex
France	Centre Leon Berard	Lyon
France	Centre Hospitalier Universitaire Nord	Marseille Cedex 20
France	Institut Curie	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Benite cedex
France	Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou	Rennes Cedex 9
France	Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil	Strasbourg Cedex
France	Centre Hospitalier Universitaire de Toulouse - Hopital Larrey	Toulouse Cedex 9
France	Gustave Roussy	Villejuif
Germany	Charite Universitaetsmedizin Berlin, Campus Virchow	Berlin
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Universitaetsklinikum Essen	Essen
Germany	Asklepios Fachkliniken Muenchen Gauting	Gauting
Germany	LungenClinic Grosshansdorf GmbH	Grosshansdorf
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Greece	Alexandra Hospital	Athens
Greece	Henry Dunant Hospital Center	Athens
Greece	Saint Savas Hospital	Athens
Greece	Thoracic General Hospital Of Athens Sotiria	Athens
Greece	University Hospital of Heraklion	Heraklion - Crete
Greece	Olympion Therapeftirio General Clinic Of Patras	Patra
Greece	European Interbalkan Medical Center	Thessaloniki
Greece	Saint Luke Hospital	Thessaloniki
Hungary	Orszagos Koranyi Pulmonologiai Intezet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Matrai Gyogyintezet	Gyongyos
Hungary	Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar
Hungary	Komarom-Esztergom Varmegyei Szent Borbala Korhaz	Tatabanya
Hungary	Reformatus Pulmonologiai Centrum	Torokbalint
Ireland	Beaumont Hospital	Dublin
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Ein-Kerem Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva
Italy	Humanitas Gavazzeni	Bergamo
Italy	Azienda Ospedaliera Universitaria Renato Dulbecco	Catanzaro
Italy	Ospedale Policlinico San Martino IRCCS	Genova
Italy	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori	Meldola (FC)
Italy	Azienda Ospedaliera Universitaria San Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliera San Giovanni Addolorata	Roma
Japan	Hyogo Cancer Center	Akashi-shi	Hyogo
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Saitama Medical University International Medical Center	Hidaka-Shi	Saitama
Japan	Kansai Medical University Hospital	Hirakata-shi	Osaka
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Koto-ku	Tokyo
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-shi	Ehime
Japan	Aichi Cancer Center	Nagoya-shi	Aichi
Japan	National Hospital Organization Nagoya Medical Center	Nagoya-shi	Aichi
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	Okayama University Hospital	Okayama-shi	Okayama
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo-shi	Hokkaido
Japan	Sendai Kousei Hospital	Sendai-shi	Miyagi
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Wakayama Medical University Hospital	Wakayama-shi	Wakayama
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center	Yokohama-shi	Kanagawa
Korea, Republic of	Chungbuk National University Hospital	Cheongju Chungbuk
Korea, Republic of	National Cancer Center	Goyang-si Gyeonggi-do
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Gyeongsang National University Hospital	Jinju-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St Marys Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Mexico	Oncare	Ciudad de México	Distrito Federal
Mexico	Health Pharma Professional Research SA de CV	Mexico City	Distrito Federal
Mexico	coi Centro Oncologico Internacional sapi de cv	Tlajomulco de Zúñiga	Jalisco
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Centrum Pulmonologii i Torakochirurgii w Bystrej	Bystra
Poland	Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo	Krakow
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow	Poznan
Portugal	Hospital Cuf Descobertas	Lisboa
Portugal	Hospital da Luz, SA	Lisboa
Portugal	Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano	Matosinhos
Portugal	Hospital Cuf porto	Porto
Romania	Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca	Cluj Napoca
Romania	Centrul de Oncologie Sf Nectarie SRL	Craiova
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	SC Oncomed SRL	Timisoara
Singapore	National Cancer Centre Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Spain	Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera	A Coruña	Galicia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Universitari Vall d Hebron	Barcelona	Cataluña
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga	Andalucía
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza	Aragón
Switzerland	Kantonsspital Graubuenden	Chur
Switzerland	Freiburg Spital	Fribourg
Switzerland	Hopitaux universitaires de Geneve	Geneve 14
Switzerland	Kantonsspital Sankt Gallen	Sankt Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Veterans General Hospital - Taichung	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi	Ankara
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Pamukkale Universitesi Tip Fakultesi Hastanesi	Denizli
Turkey	Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Medipol Mega Universite Hastanesi	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Izmir Ekonomi Universitesi Medical Point Hastanesi	Izmir
Turkey	Inonu Universitesi Turgut Ozal Tip Merkezi	Malatya
United Kingdom	Guys Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Christie Hospital	Manchester
United States	Alaska Oncology and Hematology	Anchorage	Alaska
United States	Trinity Health Saint Joseph Mercy Ann Arbor	Ann Arbor	Michigan
United States	Our Lady of the Lake Cancer Institute	Baton Rouge	Louisiana
United States	Northwestern University	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Missouri Health Care	Columbia	Missouri
United States	Swedish Cancer Institute Medical Oncology	Edmonds	Washington
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	Indiana U Simon Cancer Center	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Tennessee Medical Center Knoxville	Knoxville	Tennessee
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Baptist Cancer Center	Memphis	Tennessee
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University Langone Health	New York	New York
United States	Perlmutter Cancer Center at New York University Langone Hospital----Long Island	New York	New York
United States	Northport Veterans Affairs Medical Center	Northport	New York
United States	Pikeville Medical Center	Pikeville	Kentucky
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of California Los Angeles	Santa Monica	California
United States	Sanford Oncology Clinic and Pharmacy	Sioux Falls	South Dakota
United States	Summit Medical Group, Overlook Oncology Center	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Singapore,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		Up to approximately 4 years
Secondary	Progression Free Survival (PFS)		Up to approximately 4 years
Secondary	Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)		Up to approximately 4 years
Secondary	Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)		Up to approximately 4 years
Secondary	Overall Response (OR)		Up to approximately 4 years
Secondary	Disease Control (DC)		Up to approximately 4 years
Secondary	Duration of Response (DOR)		Up to approximately 4 years
Secondary	PFS		1 year
Secondary	OS		1 year, 2 years and 3 years
Secondary	Incidence of Treatment-Emergent Adverse Events (TEAE)		Up to approximately 4 years
Secondary	Serum Concentrations of Tarlatamab		Up to 1 year
Secondary	Number of Participants Who Experience Anti-tarlatamab Antibodies		Up to 1 year
Secondary	Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)		Up to approximately 4 years
Secondary	Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)		Up to approximately 4 years
Secondary	Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS)		Up to approximately 4 years
Secondary	Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)		Up to approximately 4 years
Secondary	Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire		Up to approximately 4 years
Secondary	Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire		Up to approximately 4 years
Secondary	Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire		Up to approximately 4 years

External Links

•   AmgenTrials clinical trials website