ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

— ARCHER 1009  

Official title:

Archer 1009: A Randomized, Double Blind Phase 3 Efficacy And Safety Study Of PF-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-Small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360554
• Other study ID #: A7471009
• Secondary ID: 2010-022656-22
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2011
• Last updated: January 4, 2016
• Start date: June 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Evidence of pathologically confirmed, advanced NSCLC (with known histology).

• Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).

• Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.

• Adequate renal, hematologic, liver function.

• ECOG PS of 0-2.

• Radiologically measurable disease.

Exclusion Criteria:

• Small cell histology.

• Symptomatic brain mets or known leptomeningeal mets.

• Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.

• Uncontrolled medical disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing
• Active Comparator (erlotinib)
Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing
• Placebo erlotinib
placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
• Placebo PF00299804
placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Locations

Country	Name	City	State
Austria	Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Laboratoire de la Porte de Hall	Brussels
Belgium	Grand Hopital de Charleroi Oncologie-Hematologie	Charleroi
Belgium	CHU Ambroise Parre- Service Biologie Clinique	Mons
Belgium	Heilig Hart Ziekenhuis Roeselare-Menen	Roeselare
China	Jilin Provincial Cancer Hospital	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Tumour Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Shanghai Pulmonary Hospital	Shanghai
China	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center	Wuhan	Hubei
Denmark	Aalborg Sygehus Syd	Aalborg
Finland	Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka	Helsinki
Finland	Satakunnan keskussairaala/Keuhkosairauksien osasto A4	Pori
Finland	Satakunnan Keskussairaalan laboratorio	Pori
France	Centre Georges Francois Leclerc	Dijon
France	Hopital Albert Michallon	Grenoble cedex 09
France	Hôpital Paris Saint Joseph	Paris
France	CHU de Poitiers	Poitiers Cedex
France	Institut de Cancerologie de lOuest - Rene Gauducheau	Saint Herblain cedex
Germany	Universitaetsklinikum Aachen	Aachen
Germany	Asklepios Fachkliniken Muenchen-Gauting	Gauting
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet	Mainz
Germany	Krankenhaus Bethanien, Medizinische Klinik III	Moers
Greece	Sotiria General Hospital of Athens	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	University Hospital of Larissa	Larissa
Hungary	Semmelweis Egyetem Pulmonologiai Klinika	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum	Debrecen
Hungary	Veszprem Megyei Onkormanyzat Tudogyogyintezete	Farkasgyepu
Hungary	Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat	Gyula
Hungary	Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.	Nyiregyhaza
Hungary	Zala Megyei Korhaz, Pulmonologiai Osztaly	Zalaegerszeg-Pozva
India	Vedanta Institute of Medical Sciences	Ahmedabad	Gujarat
India	Manipal Hospital	Bangalore	Karnataka
India	Tata Memorial Centre	Mumbai	Maharashtra
India	Ruby Hall Clinic	Pune	Maharastra
Ireland	Beaumont Hospital	Dublin	Leinster
Ireland	St. Annes Oncology Unit	Dublin	Leinster
Ireland	St. James Hospital	Dublin
Ireland	Oncology Department	Waterford
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	National Cancer Center Hospital	Chuo-Ku	Tokyo
Japan	Kyushu University Hospital Respiratory Medicine	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology	Fukuoka
Japan	National Hp. Org. Kyushu Medical Center	Fukuoka
Japan	Kanazawa University Hospital Laboratory	Kanazawa-city	Ishikawa
Japan	National Cancer Center East Hospital	Kashiwa	Chiba
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	The Cancer Institute Hospital of JFCR	Koto-ku, Tokyo
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-city	Ehime
Japan	Aichi cancer center central hospital /Thoracic Oncology	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama-city	Okayama
Japan	Osaka City General Hospital Department of Clinical Oncology	Osaka-city	Osaka
Japan	Kinki University Hospital	Osakasayama-shi	Osaka
Japan	National Hospital Organization Kinki-chuo Chest Medical Center	Sakai-shi	Osaka-fu
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	National Hospital Organization, Yamaguchi-Ube Medical Center	Ube-shi	Yamaguchi
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama	Kanagawa
Korea, Republic of	Asan Medical Center, Department of Oncology	Seoul
Korea, Republic of	Samsung Medical Center, Clinical Trial Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Oaxaca Site Management Organization	Oaxaca
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy	Otwock	Mazowieckie
Poland	Zoz All-Medi	Otwock	Mazowieckie
Poland	Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie	Warsaw	Mazowieckie
Poland	Nukleomed	Warsaw	Mazowieckie
Russian Federation	City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association	Krasnodar	Krasnodarskij Kraj
Russian Federation	Pyatigorsk Oncology dispensary	Pyatigorsk
Russian Federation	City Clinical Oncology Dispensary	Saint-Petersburg
Russian Federation	City Clinical Oncology Dispensary	Saint-Petersburg
Russian Federation	Clinic of Hospital Surgery	Saint-Petersburg
Russian Federation	Military Medical Academy n.a. S.M.Kirov	Saint-Petersburg
Russian Federation	Research Institute of Pulmonology	Saint-Petersburg
Russian Federation	Russian Scientific Center of Radiology and Surgical Technologies	Saint-Petersburg
Russian Federation	St.-Petersburg State Medical University I.P.Pavlov of Roszdrav	Saint-Petersburg
Russian Federation	Samara Regional Clinical Oncology Dispensary	Samara
Russian Federation	Oncology Center # 2	Sochi	Krasnodarskij Kraj
Slovakia	Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie	Bratislava
Slovakia	Specializovana nemocnica sv. Svorada Zobor, n.o.	Nitra
Slovakia	Fakultna nemocnica s poliklinikou	Nove Zamky
South Africa	Department of Oncotherapy	Bloemfontein
South Africa	WCR: Wits Clinical Research	Johannesburg	Gauteng
South Africa	WITS Donald Gordon Clinical Trial Site	Johannesburg	Gauteng
South Africa	GVI Oncology Clinical Research Unit	Kraaifontein	Western Cape
South Africa	GVI Oncology	Port Elizabeth
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau - AGDAC	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau - Anatomia Patológica	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau - Hospital de Día	Barcelona
Spain	HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy	Barcelona
Spain	Hospital Provincial de Castellon (Farmacia)	Castellon
Spain	Hospital Provincial de Castellon - Servicio de Oncologia	Castellón	Castellon
Spain	Hospital General Universitario de Elche - Edificio UIAE	Elche	Alicante
Spain	Hospital Universitario 12 de Octubre-Radiology	Madrid
Spain	Hospital Universitario 12 de Octubre01	Madrid
Spain	Hospital Universitario Madrid Sanchinarro	Madrid
Spain	Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.	Sevilla
Sweden	KPE/Onkologikliniken	Karlstad
Sweden	Karolinska Universitetssjukhuset	Stockholm
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Istituto Oncologico della Svizzera Italiana	Bellinzona
Switzerland	Hopitaux Universitaires de Geneve	Geneve 14
Switzerland	Ospedale Regionale di Locarno La Carita	Locarno
Switzerland	Kantonsspital St. Gallen	St. Gallen
United Kingdom	North Middlesex NHS Trust	Edmonton
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Cancer Clinical Trials Unit	London
United Kingdom	North Middlesex NHS Trust	London
United Kingdom	Oncology Research, Podium,	London
United Kingdom	Kent Oncology Centre	Maidstone	Kent
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	Christie Hospital NHS Trust, Department of Medical Oncology	Manchester
United Kingdom	Lung and Melanoma Research Team	Manchester
United Kingdom	New Cross Hospital - Royal Wolverhampton Hospital NHS Trust	Wolverhampton
United Kingdom	New Cross Hospital - Royal Wolverhampton Hospital NHS Trust	Wolverhampton	West Midlands
United Kingdom	New Cross Hospital, Pharmacy Department	Wolverhampton
United States	Central Hematology Oncology Medical Group Inc.	Alhambra	California
United States	UCLA Hematology Oncology-Alhambra	Alhambra	California
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Emory Clinic	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Northwest Georgia Oncology Centers, P.C.	Austell	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwest Georgia Oncology Centers, P.C.	Carrollton	Georgia
United States	Northwest Georgia Oncology Centers, PC	Cartersville	Georgia
United States	Ironwood Cancer and Research Centers P. C.	Chandler	Arizona
United States	Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers	Chandler	Arizona
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Good Samaritan Hospital Samaritan Ambulatory Infusion Services	Corvallis	Oregon
United States	Samaritan Hematology & Oncology Consultants	Corvallis	Oregon
United States	Samaritan Pharmacy Services	Corvallis	Oregon
United States	Siteman Cancer Center-West County	Creve Couer	Missouri
United States	Atlanta Cancer Care	Decatur	Georgia
United States	Georgia Cancer Specialists	Decatur	Georgia
United States	The Cancer Center at DeKalb Medical	Decatur	Georgia
United States	Oncology and Hematology Specialists, P.A.	Denville	New Jersey
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Northwest Georgia Oncology Centers, P.C.	Douglasville	Georgia
United States	City of Hope	Duarte	California
United States	Suburban Hematology-Oncology Associates, P.C.	Duluth	Georgia
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Karmanos Cancer Institute at Farmington Hills	Farmington Hills	Michigan
United States	Highlands Oncology Group PA	Fayetteville	Arkansas
United States	Northwest Alabama Cancer Center	Florence	Alabama
United States	St. Jude Heritage Healthcare	Fullerton	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Oncology Specialists of North Georgia, LLC	Gainesville	Georgia
United States	The Longstreet Clinic Cancer Center	Gainesville	Georgia
United States	Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers	Gilbert	Arizona
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Ingalls Memorial Hospital - In-Patient Pharmacy	Harvey	Illinois
United States	Monroe Medical Associates	Harvey	Illinois
United States	Kentucky Cancer Clinic	Hazard	Kentucky
United States	Carolina Oncology Specialists PA	Hickory	North Carolina
United States	Kadlec Clinic Hematology and Oncology	Kennewick	Washington
United States	Suburban Hematology-Oncology Associates, P.C.	Lawrenceville	Georgia
United States	Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital	Lebanon	New Hampshire
United States	Carolina Oncology Specialists PA	Lenoir	North Carolina
United States	Samaritan North Lincoln Hospital	Lincoln City	Oregon
United States	Texas Oncology-Longview Cancer Center	Longview	Texas
United States	Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)	Los Angeles	California
United States	Drug Management Only	Los Angeles	California
United States	Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center	Los Angeles	California
United States	Regulatory Management:	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	TORI Central Administration	Los Angeles	California
United States	UCLA West Medical Pharmacy	Los Angeles	California
United States	Westwood Bowyer Clinic, Peter Morton Medical Building	Los Angeles	California
United States	Baptist Hospital East	Louisville	Kentucky
United States	University Medical Center, Inc	Louisville	Kentucky
United States	University Medical Center, Inc.	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Desert Oncology Associates dba Ironwood Cancer and Research Centers	Mesa	Arizona
United States	Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers	Mesa	Arizona
United States	University of South Alabama Medical Center	Mobile	Alabama
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	Monroe Medical Associates	Munster	Indiana
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Samaritan Pacific Communities Hospital	Newport	Oregon
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Mercy Physicians of Oklahoma	Oklahoma City	Oklahoma
United States	Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley	Oklahoma City	Oklahoma
United States	Cancer Institute of Florida	Orlando	Florida
United States	Florida Hospital	Orlando	Florida
United States	Hematology and Oncology Consultants, P.A.	Orlando	Florida
United States	Investigational Drug Services, Florida Hospital	Orlando	Florida
United States	Central Hematology Oncology Medical Group, Inc.	Pasadena	California
United States	UCLA/Pasadena Healthcare Hematology-Oncology	Pasadena	California
United States	Hematology Oncology Associates of the Treasure Coast	Port St. Lucie	Florida
United States	Cancer Care Associates Medical Group Inc.	Redondo Beach	California
United States	Kadlec Medical Center	Richland	Washington
United States	Outpatient Imaging Center	Richland	Washington
United States	Highlands Oncology Group, PA	Rogers	Arkansas
United States	Siteman Cancer Center-St. Peters	Saint Peters	Missouri
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	UCLA Hematology Oncology-Parkside	Santa Monica	California
United States	UCLA Hematology Oncology-Santa Monica	Santa Monica	California
United States	UCLA Santa Monica Medical Center & Orthopedic Hospital	Santa Monica	California
United States	Guthrie Clinic, Limited	Sayre	Pennsylvania
United States	Robert Packer Hospital	Sayre	Pennsylvania
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Suburban Hematology-Oncology Associates	Snellville	Georgia
United States	City of Hope South Pasadena Cancer Center	South Pasadena	California
United States	Barnes Jewish Hospital	St. Louis	Missouri
United States	Washington University School of Medicine-IDS Pharmacy	St. Louis	Missouri
United States	North Mississippi Hematology and Oncology Associates, Ltd.	Starkville	Mississippi
United States	Stony Brook University-Cancer Center	Stony Brook	New York
United States	Monroe Medical Associates	Tinley Park	Illinois
United States	North Mississippi Hematology and Oncology Associates, Ltd.,	Tupelo	Mississippi
United States	Texas Oncology-Tyler	Tyler	Texas
United States	UCLA/Santa Clarita Valley Cancer Center	Valencia	California
United States	Texas Oncology - Waco	Waco	Texas
United States	Cedar Valley Medical Specialists, P.C.	Waterloo	Iowa
United States	UCLA Cancer Center	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  China,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival per Independent Radiologic review in two co-primary populations.		10 months after anticipated LSLV	No
Secondary	Overall Survival		12 months after anticipated LSLV	No
Secondary	Progression-Free Survival per Investigator		4 months after anticipated LSLV	No
Secondary	Best Overall Response		6 months after	No
Secondary	Duration of Response		6 months from LSLV until progression	No
Secondary	Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 months		until resolution of any unresolved treatment-related adverse event for 6 months from LSLV	Yes
Secondary	Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status		6 months from LSLV	No
Secondary	KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline		baseline, and 12 months from LSLV	No
Secondary	PK trough concentrations		12 months from LSLV	No

External Links

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