search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dacomitinib (PF-00299804)
Active Comparator (erlotinib)
Placebo erlotinib
Placebo PF00299804
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring comparative study of PF-00299804 and Erlotinib, Double-Blind Phase 3 trial of TKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham
  • University of Alabama at Birmingham
  • Northwest Alabama Cancer Center
  • University of South Alabama Mitchell Cancer Institute
  • University of South Alabama Medical Center
  • Northwest Alabama Cancer Center
  • Ironwood physicians P C dba Ironwood Cancer & Research Centers
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  • Desert Oncology Associates dba Ironwood Cancer and Research Centers
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
  • Highlands Oncology Group PA
  • Highlands Oncology Group, PA
  • Central Hematology Oncology Medical Group Inc.
  • UCLA Hematology Oncology-Alhambra
  • City of Hope
  • St. Jude Heritage Healthcare
  • Drug Management Only
  • Drug Managerrent Only:
  • UCLA West Medical Pharmacy
  • Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)
  • Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center
  • Regulatory Management Only:
  • Regulatory Management:
  • Ronald Reagan UCLA Medical Center
  • TORI Central Administration
  • Westwood Bowyer Clinic, Peter Morton Medical Building
  • UCLA/Pasadena Healthcare Hematology-Oncology
  • Central Hematology Oncology Medical Group, Inc.
  • Cancer Care Associates Medical Group Inc.
  • Central Coast Medical Oncology Corporation
  • UCLA Hematology Oncology-Parkside
  • UCLA Hematology Oncology-Santa Monica
  • UCLA Santa Monica Medical Center & Orthopedic Hospital
  • City of Hope South Pasadena Cancer Center
  • UCLA/Santa Clarita Valley Cancer Center
  • UCLA Cancer Center
  • Norwalk Hospital
  • Florida Hospital
  • Cancer Institute of Florida
  • Hematology and Oncology Consultants, P.A.
  • Investigational Drug Services, Florida Hospital
  • Hematology Oncology Associates of the Treasure Coast
  • Emory University Hospital Midtown
  • Emory Clinic
  • Emory University Hospital
  • Winship Cancer Institute of Emory University
  • Northwest Georgia Oncology Centers, P.C.
  • Northwest Georgia Oncology Centers, P.C.
  • Northwest Georgia Oncology Centers, PC
  • John B. Amos Cancer Center
  • Atlanta Cancer Care
  • Georgia Cancer Specialists
  • The Cancer Center at DeKalb Medical
  • Northwest Georgia Oncology Centers, P.C.
  • Suburban Hematology-Oncology Associates, P.C.
  • Northeast Georgia Medical Center
  • Oncology Specialists of North Georgia, LLC
  • The Longstreet Clinic Cancer Center
  • Suburban Hematology-Oncology Associates, P.C.
  • Northwest Georgia Oncology Centers, P.C.
  • Suburban Hematology-Oncology Associates, P.C.
  • Illinois Cancer Specialists
  • Ingalls Memorial Hospital - In-Patient Pharmacy
  • Ingalls Memorial Hospital
  • Monroe Medical Associates
  • Illinois Cancer Specialists
  • Monroe Medical Associates
  • Deaconess Clinic Downtown
  • Monroe Medical Associates
  • Cedar Valley Medical Specialists, P.C.
  • Kentucky Cancer Clinic
  • University Medical Center, Inc.
  • University Medical Center, Inc
  • Baptist Hospital East
  • Karmanos Cancer Institute
  • Karmanos Cancer Institute at Farmington Hills
  • North Mississippi Hematology and Oncology Associates, Ltd.
  • North Mississippi Hematology and Oncology Associates, Ltd.,
  • Siteman Cancer Center-West County
  • Barnes Jewish Hospital
  • Washington University School of Medicine-IDS Pharmacy
  • Siteman Cancer Center-St. Peters
  • Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital
  • Oncology and Hematology Specialists, P.A.
  • Stony Brook University-Cancer Center
  • Carolina Oncology Specialists PA
  • Carolina Oncology Specialists PA
  • Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman
  • Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
  • Mercy Hospital Oklahoma City - Oncology Infusion
  • Good Samaritan Hospital Samaritan Ambulatory Infusion Services
  • Samaritan Hematology & Oncology Consultants
  • Samaritan Pharmacy Services
  • Samaritan North Lincoln Hospital
  • Samaritan Pacific Communities Hospital
  • Guthrie Clinic, Limited
  • Robert Packer Hospital
  • Texas Oncology-Longview Cancer Center
  • Texas Oncology-Tyler
  • Texas Oncology - Waco
  • Kadlec Clinic Hematology and Oncology
  • Kadlec Medical Center
  • Outpatient Imaging Center
  • Seattle Cancer Care Alliance
  • University of Washington Medical Center
  • Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum
  • Institut Jules Bordet
  • Laboratoire de la Porte de Hall
  • Grand Hopital de Charleroi Oncologie-Hematologie
  • CHU Ambroise Parre- Service Biologie Clinique
  • Heilig Hart Ziekenhuis Roeselare-Menen
  • Tumour Hospital of Guangxi Zhuang Autonomous Region
  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
  • Jilin Provincial Cancer Hospital
  • West China Hospital of Sichuan University
  • Shanghai Pulmonary Hospital
  • Aalborg Sygehus Syd
  • Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka
  • Satakunnan keskussairaala/Keuhkosairauksien osasto A4
  • Centre Georges Francois Leclerc
  • Hopital Albert Michallon
  • Hôpital Paris Saint Joseph
  • CHU de Poitiers
  • Institut de Cancerologie de lOuest - Rene Gauducheau
  • Universitaetsklinikum Aachen
  • Asklepios Fachkliniken Muenchen-Gauting
  • Lungenfachklinik Immenhausen
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet
  • Krankenhaus Bethanien, Medizinische Klinik III
  • University Hospital of Larissa
  • Sotiria General Hospital of Athens
  • University Hospital of Heraklion
  • Semmelweis Egyetem Pulmonologiai Klinika
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Veszprem Megyei Onkormanyzat Tudogyogyintezete
  • Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat
  • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
  • Zala Megyei Korhaz, Pulmonologiai Osztaly
  • Vedanta Institute of Medical Sciences
  • Manipal Hospital
  • Tata Memorial Centre
  • Ruby Hall Clinic
  • St Vincent's University Hospital
  • Beaumont Hospital
  • St. James Hospital
  • Oncology Department
  • Aichi cancer center central hospital /Thoracic Oncology
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • National Hospital Organization Asahikawa Medical Center
  • Hyogo Cancer Center
  • Kanazawa University Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Tohoku University Hospital
  • Kurashiki Central Hospital
  • Okayama University Hospital
  • National Hospital Organization Kinki-chuo Chest Medical Center
  • Osaka City General Hospital Department of Clinical Oncology
  • Kinki University Hospital
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • National Hospital Organization, Yamaguchi-Ube Medical Center
  • National Hp. Org. Kyushu Medical Center
  • National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
  • Kyushu University Hospital Respiratory Medicine
  • The Cancer Institute Hospital of JFCR
  • Seoul National University Hospital
  • Samsung Medical Center, Clinical Trial Center
  • Asan Medical Center, Department of Oncology
  • Oaxaca Site Management Organization
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Zoz All-Medi
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
  • Nukleomed
  • City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association
  • Oncology Center # 2
  • Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency
  • Pyatigorsk Oncology Center
  • Clinic of Hospital Surgery
  • Military Medical Academy n.a. S.M.Kirov
  • City Clinical Oncology Dispensary
  • St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
  • Research Institute of Pulmonology
  • Russian Scientific Center of Radiology and Surgical Technologies
  • City Clinical Oncology Dispensary
  • Samara Regional Clinical Oncology Dispensary
  • Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie
  • Specializovana nemocnica sv. Svorada Zobor, n.o.
  • Fakultna nemocnica s poliklinikou
  • WCR: Wits Clinical Research
  • GVI Oncology Clinical Research Unit
  • Department of Oncotherapy
  • GVI Oncology
  • Hospital General Universitario de Elche - Edificio UIAE
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Provincial de Castellon - Servicio de Oncologia
  • HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy
  • Hospital de la Santa Creu i Sant Pau - AGDAC
  • Hospital de la Santa Creu i Sant Pau - Anatomia Patológica
  • Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear
  • Hospital de la Santa Creu i Sant Pau - Hospital de Día
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Provincial de Castellon (Farmacia)
  • Hospital Universitario 12 de Octubre-Radiology
  • Hospital Universitario 12 de Octubre01
  • Hospital Universitario Madrid Sanchinarro
  • Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.
  • KPE/Onkologikliniken
  • Karolinska Universitetssjukhuset
  • Kantonsspital Aarau
  • Istituto Oncologico della Svizzera Italiana
  • Hopitaux Universitaires de Geneve
  • Ospedale Regionale di Locarno La Carita
  • Kantonsspital St. Gallen
  • Kent Oncology Centre
  • New Cross Hospital - Royal Wolverhampton Hospital NHS Trust
  • North Middlesex NHS Trust
  • Leicester Royal Infirmary
  • Cancer Clinical Trials Unit
  • Christie Hospital NHS Trust, Department of Medical Oncology
  • Christie Hospital NHS Trust
  • Lung and Melanoma Research Team

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Blinded active PF-00299804 + blinded placebo comparator (erlotinib)

Blinded active comparator (erlotinib) + blinded placebo PF-00299804

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Per Independent Radiologic Review.
PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.
Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.

Secondary Outcome Measures

PFS Based on Investigator Review.
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.
PFS Based on Investigator Review in KRAS-WT Participants.
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
Overall Survival (OS).
OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).
OS in KRAS-WT Participants.
OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
Best Overall Response (BOR) Per Independent Radiologic Review.
The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
BOR Per Investigator Review.
The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Duration of Response (DR) Based on Independent Radiologic Review.
DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
DR Based on Investigator Review.
DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Trough Concentrations (Ctrough) of Dacomitinib.
Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.
Trough Concentrations (Ctrough) of PF-05199265.
Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.
Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.
TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.
Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.
Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.
Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.
The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.
Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score
The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no health problems," "moderate health problems," and "extreme health problems." The EQ VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Full Information

First Posted
April 12, 2011
Last Updated
April 24, 2017
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01360554
Brief Title
ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 16, 2011 (undefined)
Primary Completion Date
September 30, 2013 (Actual)
Study Completion Date
September 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
comparative study of PF-00299804 and Erlotinib, Double-Blind Phase 3 trial of TKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
878 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Blinded active comparator (erlotinib) + blinded placebo PF-00299804
Intervention Type
Drug
Intervention Name(s)
Dacomitinib (PF-00299804)
Intervention Description
Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing
Intervention Type
Drug
Intervention Name(s)
Active Comparator (erlotinib)
Intervention Description
Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing
Intervention Type
Drug
Intervention Name(s)
Placebo erlotinib
Intervention Description
placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
Intervention Type
Drug
Intervention Name(s)
Placebo PF00299804
Intervention Description
placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Per Independent Radiologic Review.
Description
PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.
Description
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Secondary Outcome Measure Information:
Title
PFS Based on Investigator Review.
Description
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
PFS Based on Investigator Review in KRAS-WT Participants.
Description
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
Overall Survival (OS).
Description
OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).
Time Frame
From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.
Title
OS in KRAS-WT Participants.
Description
OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
Time Frame
From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.
Title
Best Overall Response (BOR) Per Independent Radiologic Review.
Description
The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Time Frame
From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
BOR Per Investigator Review.
Description
The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Time Frame
From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
Duration of Response (DR) Based on Independent Radiologic Review.
Description
DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Time Frame
From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
DR Based on Investigator Review.
Description
DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.
Time Frame
From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
Title
Trough Concentrations (Ctrough) of Dacomitinib.
Description
Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.
Time Frame
Baseline up to Cycle 5 Day 1
Title
Trough Concentrations (Ctrough) of PF-05199265.
Description
Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.
Time Frame
Baseline up to Cycle 5 Day 1
Title
Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.
Description
TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.
Time Frame
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.
Title
Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Description
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.
Time Frame
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
Title
Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.
Description
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.
Time Frame
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
Title
Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.
Description
The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.
Time Frame
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
Title
Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score
Description
The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no health problems," "moderate health problems," and "extreme health problems." The EQ VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Northwest Alabama Cancer Center
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Northwest Alabama Cancer Center
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Ironwood physicians P C dba Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Desert Oncology Associates dba Ironwood Cancer and Research Centers
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Highlands Oncology Group PA
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group, PA
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Central Hematology Oncology Medical Group Inc.
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
UCLA Hematology Oncology-Alhambra
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Drug Management Only
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
Drug Managerrent Only:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
UCLA West Medical Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Regulatory Management Only:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Regulatory Management:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TORI Central Administration
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Westwood Bowyer Clinic, Peter Morton Medical Building
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA/Pasadena Healthcare Hematology-Oncology
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Central Hematology Oncology Medical Group, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Cancer Care Associates Medical Group Inc.
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
UCLA Hematology Oncology-Parkside
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Hematology Oncology-Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Santa Monica Medical Center & Orthopedic Hospital
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
City of Hope South Pasadena Cancer Center
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Facility Name
UCLA/Santa Clarita Valley Cancer Center
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
UCLA Cancer Center
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Cancer Institute of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Hematology and Oncology Consultants, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Drug Services, Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Hematology Oncology Associates of the Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Carrollton
State/Province
Georgia
ZIP/Postal Code
30117
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30121
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Atlanta Cancer Care
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Georgia Cancer Specialists
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
The Cancer Center at DeKalb Medical
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Suburban Hematology-Oncology Associates, P.C.
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Oncology Specialists of North Georgia, LLC
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
The Longstreet Clinic Cancer Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Suburban Hematology-Oncology Associates, P.C.
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Suburban Hematology-Oncology Associates, P.C.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Ingalls Memorial Hospital - In-Patient Pharmacy
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Monroe Medical Associates
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Monroe Medical Associates
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60477
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Monroe Medical Associates
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Cedar Valley Medical Specialists, P.C.
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50701
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701-9466
Country
United States
Facility Name
University Medical Center, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Medical Center, Inc
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Baptist Hospital East
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Karmanos Cancer Institute at Farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
North Mississippi Hematology and Oncology Associates, Ltd.
City
Starkville
State/Province
Mississippi
ZIP/Postal Code
39759
Country
United States
Facility Name
North Mississippi Hematology and Oncology Associates, Ltd.,
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Siteman Cancer Center-West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1094
Country
United States
Facility Name
Washington University School of Medicine-IDS Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center-St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376-1645
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Oncology and Hematology Specialists, P.A.
City
Denville
State/Province
New Jersey
ZIP/Postal Code
07834
Country
United States
Facility Name
Stony Brook University-Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9447
Country
United States
Facility Name
Carolina Oncology Specialists PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Carolina Oncology Specialists PA
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120-8347
Country
United States
Facility Name
Mercy Hospital Oklahoma City - Oncology Infusion
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Good Samaritan Hospital Samaritan Ambulatory Infusion Services
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Samaritan Hematology & Oncology Consultants
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Samaritan Pharmacy Services
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Samaritan North Lincoln Hospital
City
Lincoln City
State/Province
Oregon
ZIP/Postal Code
97367
Country
United States
Facility Name
Samaritan Pacific Communities Hospital
City
Newport
State/Province
Oregon
ZIP/Postal Code
97365
Country
United States
Facility Name
Guthrie Clinic, Limited
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Texas Oncology-Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Kadlec Medical Center
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Outpatient Imaging Center
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Laboratoire de la Porte de Hall
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Grand Hopital de Charleroi Oncologie-Hematologie
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU Ambroise Parre- Service Biologie Clinique
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis Roeselare-Menen
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Tumour Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Jilin Provincial Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Aalborg Sygehus Syd
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Satakunnan keskussairaala/Keuhkosairauksien osasto A4
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Albert Michallon
City
Grenoble cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Institut de Cancerologie de lOuest - Rene Gauducheau
City
Saint Herblain cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Asklepios Fachkliniken Muenchen-Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Krankenhaus Bethanien, Medizinische Klinik III
City
Moers
ZIP/Postal Code
47441
Country
Germany
Facility Name
University Hospital of Larissa
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Facility Name
Sotiria General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Semmelweis Egyetem Pulmonologiai Klinika
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Veszprem Megyei Onkormanyzat Tudogyogyintezete
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
City
Nyiregyhaza
ZIP/Postal Code
4412
Country
Hungary
Facility Name
Zala Megyei Korhaz, Pulmonologiai Osztaly
City
Zalaegerszeg-Pozva
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Vedanta Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 009
Country
India
Facility Name
Manipal Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
Facility Name
Tata Memorial Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharastra
ZIP/Postal Code
411001
Country
India
Facility Name
St Vincent's University Hospital
City
Dublin
State/Province
Leinster
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
State/Province
Leinster
ZIP/Postal Code
Dublin 9
Country
Ireland
Facility Name
St. James Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Oncology Department
City
Waterford
Country
Ireland
Facility Name
Aichi cancer center central hospital /Thoracic Oncology
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama-city
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Hyogo Cancer Center
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa city
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center
City
Sakai-Shi
State/Province
Osaka-fu
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Osaka City General Hospital Department of Clinical Oncology
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Kinki University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Hospital Organization, Yamaguchi-Ube Medical Center
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
National Hp. Org. Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyushu University Hospital Respiratory Medicine
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-ku, Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Clinical Trial Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center, Department of Oncology
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Oaxaca Site Management Organization
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Zoz All-Medi
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Nukleomed
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-736
Country
Poland
Facility Name
City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association
City
Krasnodar
State/Province
Krasnodarskij Kraj
ZIP/Postal Code
350012
Country
Russian Federation
Facility Name
Oncology Center # 2
City
Sochi
State/Province
Krasnodarskij Kraj
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency
City
Pyatigorsk
State/Province
Stavropolskij Kraj
ZIP/Postal Code
357340
Country
Russian Federation
Facility Name
Pyatigorsk Oncology Center
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Clinic of Hospital Surgery
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Military Medical Academy n.a. S.M.Kirov
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Institute of Pulmonology
City
Saint-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Samara Regional Clinical Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Specializovana nemocnica sv. Svorada Zobor, n.o.
City
Nitra
ZIP/Postal Code
949 88
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou
City
Nove Zamky
ZIP/Postal Code
94034
Country
Slovakia
Facility Name
WCR: Wits Clinical Research
City
Parktown,Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
GVI Oncology Clinical Research Unit
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Department of Oncotherapy
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
GVI Oncology
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Hospital General Universitario de Elche - Edificio UIAE
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Provincial de Castellon - Servicio de Oncologia
City
Castellón
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau - AGDAC
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau - Anatomia Patológica
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau - Hospital de Día
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Provincial de Castellon (Farmacia)
City
Castellon
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre-Radiology
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre01
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
KPE/Onkologikliniken
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Bellinzona
ZIP/Postal Code
06500
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Ospedale Regionale di Locarno La Carita
City
Locarno
ZIP/Postal Code
06600
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kent Oncology Centre
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
New Cross Hospital - Royal Wolverhampton Hospital NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
North Middlesex NHS Trust
City
Edmonton
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Cancer Clinical Trials Unit
City
London
ZIP/Postal Code
NW1 2PQ
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust, Department of Medical Oncology
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Lung and Melanoma Research Team
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26768165
Citation
Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum In: Ann Oncol. 2016 Jul;27(7):1363.
Results Reference
derived
PubMed Identifier
25439691
Citation
Ramalingam SS, Janne PA, Mok T, O'Byrne K, Boyer MJ, Von Pawel J, Pluzanski A, Shtivelband M, Docampo LI, Bennouna J, Zhang H, Liang JQ, Doherty JP, Taylor I, Mather CB, Goldberg Z, O'Connell J, Paz-Ares L. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1369-78. doi: 10.1016/S1470-2045(14)70452-8. Epub 2014 Oct 15.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471009&StudyName=ARCHER%201009%20%3A%20A%20Study%20Of%20Dacomitinib%20%28PF-00299804%29%20Vs.%20Erlotinib%20In%20The%20Treatment%20Of%20Advanced%20Non-Small%20Cell%20Lung%20Cancer%20%0A
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs