Back to resultsAssess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC (SELECT-1)
Primary Purpose
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selumetinib
Docetaxel
Placebo
Pegylated G-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV focused on measuring Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; metastatic; second line treatment for Non Small Cell Lung Cancer; KRAS mutation
Eligibility Criteria
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Male or female, aged 18 years or older
- Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
- KRAS mutation positive tumour sample as determined by the designated testing laboratory
- Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Exclusion Criteria:
- Mixed small cell and non-small cell lung cancer histology.
- Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
- Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
- Other concomitant anti-cancer therapy agents excepts steroids
- Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
- Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Selumetinib + Docetaxel
Placebo + Docetaxel
Arm Description
Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Secondary Outcome Measures
Overall Survival (OS)
Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Objective Response Rate (ORR)
ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)
Duration of Response (DoR)
Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01933932
Brief Title
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
Acronym
SELECT-1
Official Title
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2013 (Actual)
Primary Completion Date
June 7, 2016 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Detailed Description
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Keywords
Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; metastatic; second line treatment for Non Small Cell Lung Cancer; KRAS mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selumetinib + Docetaxel
Arm Type
Experimental
Arm Description
Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
Arm Title
Placebo + Docetaxel
Arm Type
Experimental
Arm Description
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Selumetinib
Other Intervention Name(s)
AZD6244; ARRY-142886
Intervention Description
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Pegylated G-CSF
Other Intervention Name(s)
Pegfilgrastim 6 mg
Intervention Description
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Time Frame
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Time Frame
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Title
Objective Response Rate (ORR)
Description
ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)
Time Frame
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Title
Duration of Response (DoR)
Description
Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Time Frame
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Title
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Description
The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Time Frame
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Title
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Description
Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Time Frame
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed, written and dated informed consent prior to any study specific procedures
Male or female, aged 18 years or older
Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
KRAS mutation positive tumour sample as determined by the designated testing laboratory
Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
Exclusion Criteria:
Mixed small cell and non-small cell lung cancer histology.
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Other concomitant anti-cancer therapy agents excepts steroids
Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriella Mariani, MD
Organizational Affiliation
AstraZeneca UK, MSD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pasi Jänne, MD
Organizational Affiliation
Dana-Faber Cancer Institute, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1025ABI
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1180
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Research Site
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Site
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Research Site
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Research Site
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Research Site
City
Kurralta Park
ZIP/Postal Code
5037
Country
Australia
Facility Name
Research Site
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
Research Site
City
Wendouree
ZIP/Postal Code
3355
Country
Australia
Facility Name
Research Site
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Research Site
City
Pelotas
ZIP/Postal Code
096015-280
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01209-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Site
City
Vratza
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Research Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Research Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7520349
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7630370
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8360160
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Research Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Research Site
City
Caen
ZIP/Postal Code
F-14033
Country
France
Facility Name
Research Site
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Research Site
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
ZIP/Postal Code
69310
Country
France
Facility Name
Research Site
City
RENNES Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Research Site
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Research Site
City
Dortmund
ZIP/Postal Code
44309
Country
Germany
Facility Name
Research Site
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Research Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Research Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Research Site
City
Homburg
ZIP/Postal Code
66424
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Research Site
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Research Site
City
Moers
ZIP/Postal Code
47441
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Research Site
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Edelény
ZIP/Postal Code
3780
Country
Hungary
Facility Name
Research Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Research Site
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Research Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Research Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Research Site
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Research Site
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Research Site
City
Bergen Op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Research Site
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Research Site
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15073
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 01
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Research Site
City
Miraflores
ZIP/Postal Code
15046
Country
Peru
Facility Name
Research Site
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Research Site
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Research Site
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Research Site
City
Sucha Beskidzka
ZIP/Postal Code
34-200
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Research Site
City
Coimbra
ZIP/Postal Code
3040-316
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Research Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Research Site
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Research Site
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Vigo(Pontevedra)
ZIP/Postal Code
36204
Country
Spain
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Research Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06280
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Research Site
City
İstanbul
ZIP/Postal Code
34844
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Research Site
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
Facility Name
Research Site
City
Chernivtsі
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Research Site
City
Kharkiv Region
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Research Site
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Research Site
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Research Site
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Research Site
City
Aberdeen
ZIP/Postal Code
AB2 2ZB
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Research Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
28492898
Citation
Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.
Results Reference
derived
PubMed Identifier
26837474
Citation
Janne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1830&filename=D1532C00079_SELECT1redacted_study_protocol_approved.pdf
Description
CSP_redacted
Learn more about this trial
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
We'll reach out to this number within 24 hrs