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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022656-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Blinded active PF-00299804 + blinded placebo comparator (erlotinib) |
|
| B | Active Comparator | Blinded active comparator (erlotinib) + blinded placebo PF-00299804 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dacomitinib (PF-00299804) | Drug | Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42126170 | Derived | Breen DM, Joaquim S, Paulhus BL, Bennett D, Bernardo B, Collins S, Esquejo RM, Kim-Muller JY, Lin L, Peloquin M, Wu Z, Qiao S, Stansfield JC, Zhang BB, Rossulek MI. Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70312. doi: 10.1002/jcsm.70312. | |
| 26768165 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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There were no significant study milestones following participant enrollment, but prior to group assignment.
The study was conducted at 134 sites with 878 participants randomized in a 1:1 ratio to 1 of 2 treatment arms, of these 872 were treated. Eligible participants who provided written informed consent and met all inclusion and exclusion criteria were assigned a Single Subject Identification number and randomized by the central randomization system.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) | Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Active Comparator (erlotinib) | Drug | Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing |
|
| Placebo erlotinib | Drug | placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing. |
|
| Placebo PF00299804 | Drug | placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing |
|
| 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. |
| 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. | 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. |
| 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). | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Trough Concentrations (Ctrough) of Dacomitinib. | Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants. | Baseline up to Cycle 5 Day 1 |
| Trough Concentrations (Ctrough) of PF-05199265. | Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants. | Baseline up to Cycle 5 Day 1 |
| 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. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal. |
| 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. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
| 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. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
| 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. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
| 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). | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| Northwest Alabama Cancer Center | Florence | Alabama | 35630 | United States |
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | United States |
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States |
| Northwest Alabama Cancer Center | Muscle Shoals | Alabama | 35661 | United States |
| Ironwood physicians P C dba Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | United States |
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | United States |
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | Gilbert | Arizona | 85297 | United States |
| Desert Oncology Associates dba Ironwood Cancer and Research Centers | Mesa | Arizona | 85202 | United States |
| Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers | Mesa | Arizona | 85206 | United States |
| Highlands Oncology Group PA | Fayetteville | Arkansas | 72703 | United States |
| Highlands Oncology Group, PA | Rogers | Arkansas | 72758 | United States |
| Central Hematology Oncology Medical Group Inc. | Alhambra | California | 91801 | United States |
| UCLA Hematology Oncology-Alhambra | Alhambra | California | 91801 | United States |
| City of Hope | Duarte | California | 91010 | United States |
| St. Jude Heritage Healthcare | Fullerton | California | 92835 | United States |
| Drug Management Only | Los Angeles | California | 90095-1772 | United States |
| Drug Managerrent Only: | Los Angeles | California | 90095-1772 | United States |
| UCLA West Medical Pharmacy | Los Angeles | California | 90095-1772 | United States |
| Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU) | Los Angeles | California | 90095 | United States |
| Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center | Los Angeles | California | 90095 | United States |
| Regulatory Management Only: | Los Angeles | California | 90095 | United States |
| Regulatory Management: | Los Angeles | California | 90095 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| TORI Central Administration | Los Angeles | California | 90095 | United States |
| Westwood Bowyer Clinic, Peter Morton Medical Building | Los Angeles | California | 90095 | United States |
| UCLA/Pasadena Healthcare Hematology-Oncology | Pasadena | California | 91105 | United States |
| Central Hematology Oncology Medical Group, Inc. | Pasadena | California | 91107 | United States |
| Cancer Care Associates Medical Group Inc. | Redondo Beach | California | 90277 | United States |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| UCLA Hematology Oncology-Parkside | Santa Monica | California | 90404 | United States |
| UCLA Hematology Oncology-Santa Monica | Santa Monica | California | 90404 | United States |
| UCLA Santa Monica Medical Center & Orthopedic Hospital | Santa Monica | California | 90404 | United States |
| City of Hope South Pasadena Cancer Center | South Pasadena | California | 91030 | United States |
| UCLA/Santa Clarita Valley Cancer Center | Valencia | California | 91355 | United States |
| UCLA Cancer Center | Westlake Village | California | 91361 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Cancer Institute of Florida | Orlando | Florida | 32804 | United States |
| Hematology and Oncology Consultants, P.A. | Orlando | Florida | 32804 | United States |
| Investigational Drug Services, Florida Hospital | Orlando | Florida | 32804 | United States |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Northwest Georgia Oncology Centers, P.C. | Austell | Georgia | 30106 | United States |
| Northwest Georgia Oncology Centers, P.C. | Carrollton | Georgia | 30117 | United States |
| Northwest Georgia Oncology Centers, PC | Cartersville | Georgia | 30121 | United States |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Atlanta Cancer Care | Decatur | Georgia | 30033 | United States |
| Georgia Cancer Specialists | Decatur | Georgia | 30033 | United States |
| The Cancer Center at DeKalb Medical | Decatur | Georgia | 30033 | United States |
| Northwest Georgia Oncology Centers, P.C. | Douglasville | Georgia | 30134 | United States |
| Suburban Hematology-Oncology Associates, P.C. | Duluth | Georgia | 30096 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Oncology Specialists of North Georgia, LLC | Gainesville | Georgia | 30501 | United States |
| The Longstreet Clinic Cancer Center | Gainesville | Georgia | 30501 | United States |
| Suburban Hematology-Oncology Associates, P.C. | Lawrenceville | Georgia | 30046 | United States |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | United States |
| Suburban Hematology-Oncology Associates, P.C. | Snellville | Georgia | 30078 | United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | United States |
| Ingalls Memorial Hospital - In-Patient Pharmacy | Harvey | Illinois | 60426 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Monroe Medical Associates | Harvey | Illinois | 60426 | United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | United States |
| Monroe Medical Associates | Tinley Park | Illinois | 60477 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| Monroe Medical Associates | Munster | Indiana | 46321 | United States |
| Cedar Valley Medical Specialists, P.C. | Waterloo | Iowa | 50701 | United States |
| Kentucky Cancer Clinic | Hazard | Kentucky | 41701-9466 | United States |
| University Medical Center, Inc. | Louisville | Kentucky | 40202 | United States |
| University Medical Center, Inc | Louisville | Kentucky | 40202 | United States |
| Baptist Hospital East | Louisville | Kentucky | 40207 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Karmanos Cancer Institute at Farmington Hills | Farmington Hills | Michigan | 48334 | United States |
| North Mississippi Hematology and Oncology Associates, Ltd. | Starkville | Mississippi | 39759 | United States |
| North Mississippi Hematology and Oncology Associates, Ltd., | Tupelo | Mississippi | 38801 | United States |
| Siteman Cancer Center-St. Peters | City of Saint Peters | Missouri | 63376-1645 | United States |
| Siteman Cancer Center-West County | Creve Coeur | Missouri | 63141 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110-1094 | United States |
| Washington University School of Medicine-IDS Pharmacy | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital | Lebanon | New Hampshire | 03756 | United States |
| Oncology and Hematology Specialists, P.A. | Denville | New Jersey | 07834 | United States |
| Stony Brook University-Cancer Center | Stony Brook | New York | 11794-9447 | United States |
| Carolina Oncology Specialists PA | Hickory | North Carolina | 28602 | United States |
| Carolina Oncology Specialists PA | Lenoir | North Carolina | 28645 | United States |
| Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman | Norman | Oklahoma | 73071 | United States |
| Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley | Oklahoma City | Oklahoma | 73120-8347 | United States |
| Mercy Hospital Oklahoma City - Oncology Infusion | Oklahoma City | Oklahoma | 73120 | United States |
| Good Samaritan Hospital Samaritan Ambulatory Infusion Services | Corvallis | Oregon | 97330 | United States |
| Samaritan Hematology & Oncology Consultants | Corvallis | Oregon | 97330 | United States |
| Samaritan Pharmacy Services | Corvallis | Oregon | 97330 | United States |
| Samaritan North Lincoln Hospital | Lincoln City | Oregon | 97367 | United States |
| Samaritan Pacific Communities Hospital | Newport | Oregon | 97365 | United States |
| Guthrie Clinic, Limited | Sayre | Pennsylvania | 18840 | United States |
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| Texas Oncology-Longview Cancer Center | Longview | Texas | 75601 | United States |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | United States |
| Texas Oncology - Waco | Waco | Texas | 76712 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Kadlec Medical Center | Richland | Washington | 99352 | United States |
| Outpatient Imaging Center | Richland | Washington | 99352 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum | Vienna | 1140 | Austria |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Laboratoire de la Porte de Hall | Brussels | 1000 | Belgium |
| Grand Hopital de Charleroi Oncologie-Hematologie | Charleroi | 6000 | Belgium |
| CHU Ambroise Parre- Service Biologie Clinique | Mons | 7000 | Belgium |
| Heilig Hart Ziekenhuis Roeselare-Menen | Roeselare | 8800 | Belgium |
| Tumour Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
| Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center | Wuhan | Hubei | 430023 | China |
| Jilin Provincial Cancer Hospital | Changchun | Jilin | 130012 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| Aalborg Sygehus Syd | Aalborg | 9100 | Denmark |
| Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka | Helsinki | 00290 | Finland |
| Satakunnan keskussairaala/Keuhkosairauksien osasto A4 | Pori | 28500 | Finland |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Hopital Albert Michallon | Grenoble | 38043 | France |
| Hôpital Paris Saint Joseph | Paris | 75014 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Institut de Cancerologie de lOuest - Rene Gauducheau | Saint-Herblain | 44805 | France |
| Universitaetsklinikum Aachen | Aachen | 52074 | Germany |
| Asklepios Fachkliniken Muenchen-Gauting | Gauting | 82131 | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet | Mainz | 55131 | Germany |
| Krankenhaus Bethanien, Medizinische Klinik III | Moers | 47441 | Germany |
| University Hospital of Larissa | Larissa | Thessaly | 41110 | Greece |
| Sotiria General Hospital of Athens | Athens | 11527 | Greece |
| University Hospital of Heraklion | Heraklion | 71110 | Greece |
| Semmelweis Egyetem Pulmonologiai Klinika | Budapest | 1125 | Hungary |
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum | Debrecen | 4032 | Hungary |
| Veszprem Megyei Onkormanyzat Tudogyogyintezete | Farkasgyepű | 8582 | Hungary |
| Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat | Gyula | 5703 | Hungary |
| Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. | Nyíregyháza | 4412 | Hungary |
| Zala Megyei Korhaz, Pulmonologiai Osztaly | Zalaegerszeg-Pozva | 8900 | Hungary |
| Vedanta Institute of Medical Sciences | Ahmedabad | Gujarat | 380 009 | India |
| Manipal Hospital | Bangalore | Karnataka | 560017 | India |
| Tata Memorial Centre | Mumbai | Maharashtra | 400012 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| St Vincent's University Hospital | Dublin | Leinster | Dublin 4 | Ireland |
| Beaumont Hospital | Dublin | Leinster | Dublin 9 | Ireland |
| St. James Hospital | Dublin | 8 | Ireland |
| Oncology Department | Waterford | Ireland |
| Aichi cancer center central hospital /Thoracic Oncology | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| National Hospital Organization Asahikawa Medical Center | Asahikawa | Hokkaido | 070-8644 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Yokohama | Kanagawa | 236-0051 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Kurashiki Central Hospital | Kurashiki | Okayama-ken | 710-8602 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka City General Hospital Department of Clinical Oncology | Osaka | Osaka | 534-0021 | Japan |
| Kinki University Hospital | Osakasayama-shi | Osaka | 589-8511 | Japan |
| National Hospital Organization Kinki-chuo Chest Medical Center | Sakai-Shi | Osaka | 591-8555 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| National Hospital Organization, Yamaguchi-Ube Medical Center | Ube-shi | Yamaguchi | 755-0241 | Japan |
| National Hp. Org. Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology | Fukuoka | 811-1395 | Japan |
| Kyushu University Hospital Respiratory Medicine | Fukuoka | 812-8582 | Japan |
| The Cancer Institute Hospital of JFCR | Koto-ku, Tokyo | 135-8550 | Japan |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | Masovian Voivodeship | 05-400 | Poland |
| Zoz All-Medi | Otwock | Masovian Voivodeship | 05-400 | Poland |
| Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Nukleomed | Warsaw | Masovian Voivodeship | 04-736 | Poland |
| City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association | Krasnodar | Krasnodarskiy Kray | 350012 | Russia |
| Oncology Center # 2 | Sochi | Krasnodarskiy Kray | 354057 | Russia |
| Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency | Pyatigorsk | Stavropolskij Kraj | 357340 | Russia |
| Pyatigorsk Oncology Center | Pyatigorsk | 357502 | Russia |
| Clinic of Hospital Surgery | Saint Petersburg | 194044 | Russia |
| Military Medical Academy n.a. S.M.Kirov | Saint Petersburg | 194044 | Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 197022 | Russia |
| St.-Petersburg State Medical University I.P.Pavlov of Roszdrav | Saint Petersburg | 197022 | Russia |
| Research Institute of Pulmonology | Saint Petersburg | 197089 | Russia |
| Russian Scientific Center of Radiology and Surgical Technologies | Saint Petersburg | 197758 | Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 198255 | Russia |
| Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie | Bratislava | 826 06 | Slovakia |
| Specializovana nemocnica sv. Svorada Zobor, n.o. | Nitra | 949 88 | Slovakia |
| Fakultna nemocnica s poliklinikou | Nové Zámky | 94034 | Slovakia |
| WCR: Wits Clinical Research | Parktown,Johannesburg | Gauteng | 2193 | South Africa |
| GVI Oncology Clinical Research Unit | Kraaifontein | Western Cape | 7570 | South Africa |
| Department of Oncotherapy | Bloemfontein | 9301 | South Africa |
| GVI Oncology | Port Elizabeth | 6045 | South Africa |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Samsung Medical Center, Clinical Trial Center | Seoul | 135-710 | South Korea |
| Asan Medical Center, Department of Oncology | Seoul | 138-736 | South Korea |
| Hospital General Universitario de Elche - Edificio UIAE | Elche | Alicante | 03203 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Provincial de Castellon - Servicio de Oncologia | Castellon | Castellon | 12002 | Spain |
| HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy | Barcelona | 08025 | Spain |
| Hospital de la Santa Creu i Sant Pau - AGDAC | Barcelona | 08041 | Spain |
| Hospital de la Santa Creu i Sant Pau - Anatomia Patológica | Barcelona | 08041 | Spain |
| Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear | Barcelona | 08041 | Spain |
| Hospital de la Santa Creu i Sant Pau - Hospital de Día | Barcelona | 08041 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Provincial de Castellon (Farmacia) | Castellon | Spain |
| Hospital Universitario 12 de Octubre-Radiology | Madrid | 28041 | Spain |
| Hospital Universitario 12 de Octubre01 | Madrid | 28041 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia. | Seville | 41013 | Spain |
| KPE/Onkologikliniken | Karlstad | 651 85 | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | 171 76 | Sweden |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| Istituto Oncologico della Svizzera Italiana | Bellinzona | 06500 | Switzerland |
| Hopitaux Universitaires de Geneve | Geneva | 1211 | Switzerland |
| Ospedale Regionale di Locarno La Carita | Locarno | 06600 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Kent Oncology Centre | Maidstone | Kent | ME16 9QQ | United Kingdom |
| New Cross Hospital - Royal Wolverhampton Hospital NHS Trust | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| North Middlesex NHS Trust | Edmonton | N18 1QX | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Cancer Clinical Trials Unit | London | NW1 2PQ | United Kingdom |
| Christie Hospital NHS Trust, Department of Medical Oncology | Manchester | M20 4BX | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| Lung and Melanoma Research Team | Manchester | M20 4BX | United Kingdom |
| 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. |
| 25439691 | Derived | 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. |
| FG001 |
| Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) |
Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population included all treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) | Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
| BG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Primary | 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. | ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | 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. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | 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. | ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | 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). | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | 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. | ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | 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. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Number | Participants | 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. |
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| Secondary | 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. | The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized. | Posted | Number | Participants | 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. |
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| Secondary | 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 was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | 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. | DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response. | Posted | Median | 95% Confidence Interval | Months | 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. |
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| Secondary | Trough Concentrations (Ctrough) of Dacomitinib. | Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants. | Participants treated with dacomitinib with at least one measured plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | Trough Plasma Concentration (ng/mL) | Baseline up to Cycle 5 Day 1 |
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| Secondary | Trough Concentrations (Ctrough) of PF-05199265. | Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants. | Participants treated with dacomitinib with at least one measured plasma concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | Trough Plasma Concentration (ng/mL) | Baseline up to Cycle 5 Day 1 |
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| Secondary | 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. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Posted | Median | 95% Confidence Interval | Months | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal. |
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| Secondary | 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. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
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| Secondary | 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. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
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| Secondary | 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. | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
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| Secondary | 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). | The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale. | Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. |
|
AE reporting period is from 1st dose of study drug through 28 days after last dose of study drug. SAE reporting period is from informed consent through 28 days after last dose of study drug. The longest duration of treatment in this study was 48 weeks.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) | Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. | 178 | 436 | 424 | 436 | ||
| EG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. | 169 | 436 | 417 | 436 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Splenic infarction | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Retinal artery embolism | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acne pustular | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspiration bronchial | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 18.0 | Non-systematic Assessment |
| |
| Internal fixation of fracture | Surgical and medical procedures | MedDRA 18.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C525726 | dacomitinib |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| OG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
|
|
|
Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
|
|
|
| OG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
|
|
|
|
|
|
Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
|
|
|
| OG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
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| OG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
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| OG001 | Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) | Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
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| OG001 |
| Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) |
Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
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Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death. |
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