Non-Small Cell Lung Cancer (NSCLC) Clinical Trial
— ARCHER 1009Official 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
Verified date | January 2016 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
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,
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 |
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