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Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment. (SELECT-2)

Primary Purpose

Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selumetinib 75 mg
Docetaxel 75 mg/m2
Docetaxel 60 mg/m2
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
  • Prospective confirmation of KRAS mutation negative status as determined via an AZ approved 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.
  • Other concomitant anti-cancer therapy agents except steroids
  • Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
  • The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2

Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2

Placebo twice daily + Docetaxel 75 mg/m2

Arm Description

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.

Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 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)
Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.

Secondary Outcome Measures

Overall Survival (OS)
The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive

Full Information

First Posted
December 12, 2012
Last Updated
October 12, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01750281
Brief Title
Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Acronym
SELECT-2
Official Title
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 18, 2012 (Actual)
Primary Completion Date
January 27, 2016 (Actual)
Study Completion Date
October 31, 2022 (Actual)

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 treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients
Detailed Description
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2
Arm Type
Experimental
Arm Description
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
Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2
Arm Type
Experimental
Arm Description
Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Arm Title
Placebo twice daily + Docetaxel 75 mg/m2
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 75 mg
Intervention Description
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Intervention Type
Drug
Intervention Name(s)
Docetaxel 75 mg/m2
Intervention Description
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Docetaxel 60 mg/m2
Intervention Description
Docetaxel 60 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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.
Time Frame
Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive
Time Frame
Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)

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) Prospective confirmation of KRAS mutation negative status as determined via an AZ approved 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. Other concomitant anti-cancer therapy agents except steroids Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable) The last radiation therapy within 4 weeks prior to 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 Janne, MD
Organizational Affiliation
Dana-Farber Cancer Institute, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Charles Soria, MD
Organizational Affiliation
Institut de Cancerology Gustave Roussy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Hollywood
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
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
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
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
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
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
70390-055
Country
Brazil
Facility Name
Research Site
City
Ijuí
ZIP/Postal Code
98700-000
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
90619-900
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04039-002
Country
Brazil
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
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
Sofia
ZIP/Postal Code
1756
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
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
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
ZIP/Postal Code
69310
Country
France
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Research Site
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Research Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Research Site
City
Karlsruhe
ZIP/Postal Code
76137
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
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
1032
Country
Hungary
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
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
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
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
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-848
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

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
29045535
Citation
Soria JC, Fulop A, Maciel C, Fischer JR, Girotto G, Lago S, Smit E, Ostoros G, Eberhardt WEE, Lishkovska P, Lovick S, Mariani G, McKeown A, Kilgour E, Smith P, Bowen K, Kohlmann A, Carlile DJ, Janne PA. SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2017 Dec 1;28(12):3028-3036. doi: 10.1093/annonc/mdx628.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1532C00064&attachmentIdentifier=fcbb09ba-0d2c-4d3b-8b1b-962bedef9990&fileName=CSR_Synopsis_Redacted.pdf&versionIdentifier=
Description
CSR Synopsis Redacted

Learn more about this trial

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

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