search
Back to results

A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erlotinib
PF-00299804
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Lung cancer, advanced, second or third line

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  • progressed after 1-2 prior chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) 0-2;
  • tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

  • prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  • active or untreated Central Nervous System (CNS) metastases;

Sites / Locations

  • Northwest Alabama Cancer Center
  • Agajanian Institute of Oncology and Hematology
  • Bridgeport Hospital
  • Wittingham Cancer Center @ Norwalk Hospital
  • Medical Oncology & Hematology, P.C.
  • Winship Cancer Institute at Grady Health Systems
  • Winship Cancer Institute, Emory University
  • Winship Cancer Institute at Emory University
  • Winship Cancer Institute of Emory University
  • Winship Cancer Institute, Emory University
  • Augusta Oncology Associates, P.C.
  • Augusta Oncology Associates, PC
  • John B. Amos Cancer Center
  • Georgia Cancer Specialists
  • The Longstreet Cancer Center
  • Central Georgia Cancer Care, P.C.
  • Northwest Georgia Oncology Center
  • Central Georgia Cancer Care, P.C.
  • Kootenai Cancer Center at Post Falls
  • Kootenai Cancer Center
  • Midwestern Regional Medical Center
  • Center for Blood and Cancer Disorders
  • Associates in Oncology/Hematology, PC
  • University of Minnesota Cancer Center
  • The West Clinic
  • Oncology/Hematology Associates
  • Chris O'Brien Lifehouse
  • St. Vincent's Hospital
  • The Andrew Love Cancer Centre,
  • Border Medical Oncology
  • Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
  • Hospital Sao Lucas da PUCRS
  • FUNDACAO PIO XII Hospital de Cancer de Barretos
  • Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
  • BC Cancer Agency - Vancouver Centre
  • Royal Victoria Hospital
  • RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
  • The Ottawa Hospital Cancer Centre
  • Department of Clinical Oncology
  • Department of Clinical Oncology, Tuen Mun Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
  • SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
  • Medex spolka cywilna
  • ¿KardioDent¿
  • "Vesalius" Sp. z o.o.
  • Zaklad Rentgena i USG Wyrobek spolka jawna
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
  • Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne
  • Ponce School of Medicine / CAIMED Center
  • National Cancer Centre
  • Hospital Universitari Germans Trias I Pujol
  • Hospital Son Llatzer
  • Hospital de Cruces
  • Hospital Teresa Herrera
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital, Chest Department
  • Christie Hospital NHS Foundation Trust
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Secondary Outcome Measures

Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.
Dermatology Life Quality Index (DLQI)
DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.
Percentage of Participants With Objective Response
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Best Overall Response (BOR)
Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Duration of Response (DR)
Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Overall Survival (OS)
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.

Full Information

First Posted
October 7, 2008
Last Updated
September 22, 2015
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00769067
Brief Title
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Official Title
A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung cancer, advanced, second or third line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
Continuous oral dosing at 150 mg daily.
Intervention Type
Drug
Intervention Name(s)
PF-00299804
Intervention Description
Continuous oral dosing at 45mg daily
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time Frame
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Secondary Outcome Measure Information:
Title
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.
Time Frame
Baseline up to Cycle 44 (Week 188)
Title
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)
Description
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.
Time Frame
Baseline up to Cycle 44 (Week 188)
Title
Dermatology Life Quality Index (DLQI)
Description
DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.
Time Frame
Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
Title
Percentage of Participants With Objective Response
Description
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Time Frame
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Title
Best Overall Response (BOR)
Description
Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time Frame
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Title
Duration of Response (DR)
Description
Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame
Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Title
Overall Survival (OS)
Description
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.
Time Frame
Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.
Other Pre-specified Outcome Measures:
Title
Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation
Description
Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as "unknown". Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.
Time Frame
Baseline
Title
Soluble Protein Biomarkers Level
Description
Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.
Time Frame
Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)
Title
Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)
Description
Only participants from "Dacomitinib" treatment arm were planned to be analyzed for this outcome.
Time Frame
C1D10-14, C2D1, C3D1, C4D1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: advanced measurable Non-Small Cell Lung Cancer (NSCLC); progressed after 1-2 prior chemotherapy; Eastern Cooperative Oncology Group (ECOG) 0-2; tissue available for future KRAS/ EGFR testing Exclusion Criteria: prior Epidermal Growth Factor Receptor (EGFR) targeted therapy; active or untreated Central Nervous System (CNS) metastases;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Alabama Cancer Center
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Agajanian Institute of Oncology and Hematology
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Wittingham Cancer Center @ Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Medical Oncology & Hematology, P.C.
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Winship Cancer Institute at Grady Health Systems
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Winship Cancer Institute at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta Oncology Associates, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Augusta Oncology Associates, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Georgia Cancer Specialists
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
The Longstreet Cancer Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Central Georgia Cancer Care, P.C.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwest Georgia Oncology Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Central Georgia Cancer Care, P.C.
City
Warner Robins
State/Province
Georgia
ZIP/Postal Code
31088-2259
Country
United States
Facility Name
Kootenai Cancer Center at Post Falls
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Center for Blood and Cancer Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Associates in Oncology/Hematology, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Oncology/Hematology Associates
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Andrew Love Cancer Centre,
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
FUNDACAO PIO XII Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
BC Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Department of Clinical Oncology
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Department of Clinical Oncology, Tuen Mun Hospital
City
Tuen Mun
State/Province
New Territories
Country
Hong Kong
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Medex spolka cywilna
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
¿KardioDent¿
City
Krakow
ZIP/Postal Code
30-045
Country
Poland
Facility Name
"Vesalius" Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-108
Country
Poland
Facility Name
Zaklad Rentgena i USG Wyrobek spolka jawna
City
Krakow
ZIP/Postal Code
31-215
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Ponce School of Medicine / CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Teresa Herrera
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital, Chest Department
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26768165
Citation
Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum In: Ann Oncol. 2016 Jul;27(7):1363.
Results Reference
derived

Learn more about this trial

A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

We'll reach out to this number within 24 hrs