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

October 12, 2023 updated by: AstraZeneca

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Brasilia, Brazil, 70390-055
        • Research Site
      • Ijuí, Brazil, 98700-000
        • Research Site
      • Porto Alegre, Brazil, 90035-003
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90619-900
        • Research Site
      • Santo André, Brazil, 09060-650
        • Research Site
      • Sao Paulo, Brazil, 01246-000
        • Research Site
      • Sao Paulo, Brazil, 01221-020
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São Paulo, Brazil, 04039-002
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Plovdiv, Bulgaria, 4004
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1756
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
      • Sofia, Bulgaria, 1303
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
      • Vratza, Bulgaria, 3000
        • Research Site
  • France
      • Brest Cedex, France, 29609
        • Research Site
      • Caen, France, F-14033
        • Research Site
      • Clermont Ferrand, France, 63003
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Pierre Benite Cedex, France, 69310
        • Research Site
      • Villejuif, France, 94805
        • Research Site
  • Germany
      • Essen, Germany, 45122
        • Research Site
      • Esslingen, Germany, 73730
        • Research Site
      • Großhansdorf, Germany, 22927
        • Research Site
      • Karlsruhe, Germany, 76137
        • Research Site
      • Löwenstein, Germany, 74245
        • Research Site
      • Moers, Germany, 47441
        • Research Site
      • Wiesbaden, Germany, 65199
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Budapest, Hungary, 1032
        • Research Site
      • Edelény, Hungary, 3780
        • Research Site
      • Győr, Hungary, 9024
        • Research Site
      • Kaposvár, Hungary, 7400
        • Research Site
      • Miskolc, Hungary, 3529
        • Research Site
      • Nyíregyháza, Hungary, 4400
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Bergen Op Zoom, Netherlands, 4624 VT
        • Research Site
      • Den Bosch, Netherlands, 5223 GZ
        • Research Site
      • Maastricht, Netherlands, 6202 AZ
        • Research Site
  • Poland
      • Gdańsk, Poland, 80-219
        • Research Site
      • Grudziądz, Poland, 86-300
        • Research Site
      • Kraków, Poland, 31-202
        • Research Site
      • Olsztyn, Poland, 10-357
        • Research Site
      • Poznań, Poland, 61-848
        • Research Site
      • Sucha Beskidzka, Poland, 34-200
        • Research Site
      • Szczecin, Poland, 70-891
        • Research Site
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Florida
      • Hollywood, Florida, United States, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • New York
      • Mineola, New York, United States, 11501
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • New York, New York, United States, 10011
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2
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.
Drug: Selumetinib 75 mg
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Drug: Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Experimental: Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2
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.
Drug: Selumetinib 75 mg
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Drug: Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Experimental: Placebo twice daily + Docetaxel 75 mg/m2
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.
Drug: Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Drug: Placebo
Three placebo capsules will be administered orally uninterrupted twice daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)
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.
Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
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)
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pasi Janne, MD, Dana-Farber Cancer Institute, USA
  • Principal Investigator: Jean-Charles Soria, MD, Institut de Cancerology Gustave Roussy, France
  • Study Chair: Gabriella Mariani, MD, AstraZeneca UK, MSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1532C00064
  • 2012-003622-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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