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 (SELECT-1)

November 12, 2025 updated by: AstraZeneca

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 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

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.
510

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 3

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

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1180
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1025ABI
        • Research Site
      • Córdoba, Argentina, 5000
        • Research Site
      • Rosario, Argentina, S2000KZE
        • Research Site
  • Australia
      • Camperdown, Australia, 2050
        • Research Site
      • Chermside, Australia, 4032
        • Research Site
      • Darlinghurst, Australia, 2010
        • Research Site
      • Fitzroy, Australia, 3065
        • Research Site
      • Kogarah, Australia, 2217
        • Research Site
      • Kurralta Park, Australia, 5037
        • Research Site
      • Malvern, Australia, 3144
        • Research Site
      • Wendouree, Australia, 3355
        • Research Site
      • Woodville South, Australia, 5011
        • Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Salzburg, Austria, 5020
        • Research Site
      • Vienna, Austria, 1160
        • Research Site
      • Vienna, Austria, 1100
        • Research Site
  • Belgium
      • Brussels, Belgium, 1000
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 1200
        • Research Site
      • Ghent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Ijuí, Brazil, 98700-000
        • Research Site
      • Pelotas, Brazil, 096015-280
        • Research Site
      • Porto Alegre, Brazil, 90035-003
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São Paulo, Brazil
        • Research Site
      • São Paulo, Brazil, 01209-000
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
      • Sofia, Bulgaria, 1303
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
      • Vratsa, Bulgaria, 3000
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Research Site
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Research Site
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Research Site
  • Chile
      • Santiago, Chile, 7520349
        • Research Site
      • Santiago, Chile, 8360160
        • Research Site
      • Santiago, Chile, 7500921
        • Research Site
      • Santiago, Chile, 8380456
        • Research Site
      • Santiago, Chile, 8420383
        • Research Site
      • Santiago, Chile, 7630370
        • Research Site
  • France
      • Brest, France, 29609
        • Research Site
      • Caen, France, F-14033
        • Research Site
      • Clermont-Ferrand, France, 63003
        • Research Site
      • Dijon, France, 21079
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Marseille, France, 13915
        • Research Site
      • Paris, France, 75020
        • Research Site
      • Pierre-Bénite, France, 69310
        • Research Site
      • Rennes, France, 35033
        • Research Site
      • Toulouse, France, 31059
        • Research Site
  • Germany
      • Augsburg, Germany, 86156
        • Research Site
      • Bad Berka, Germany, 99437
        • Research Site
      • Cologne, Germany, 50937
        • Research Site
      • Dortmund, Germany, 44309
        • Research Site
      • Gerlingen, Germany, 70839
        • Research Site
      • Großhansdorf, Germany, 22927
        • Research Site
      • Halle, Germany, 06120
        • Research Site
      • Heidelberg, Germany, 69126
        • Research Site
      • Homburg, Germany, 66424
        • Research Site
      • Löwenstein, Germany, 74245
        • Research Site
      • Moers, Germany, 47441
        • Research Site
      • München, Germany, 81925
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
      • Wiesbaden, Germany, 65199
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Budapest, Hungary, 1122
        • 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
      • Törökbálint, Hungary, 2045
        • Research Site
  • Israel
      • Beersheba, Israel, 8410101
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
      • Tel Litwinsky, Israel, 52621
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Genova, Italy, 16100
        • Research Site
      • Livorno, Italy, 57100
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
      • Parma, Italy, 43126
        • Research Site
      • Perugia, Italy, 06132
        • Research Site
      • Roma, Italy, 00128
        • Research Site
      • Roma, Italy, 00144
        • Research Site
  • Mexico
      • Monterrey, Mexico, 64460
        • Research Site
      • México, Mexico, 14080
        • Research Site
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Research Site
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Bergen op Zoom, Netherlands, 4624 VT
        • Research Site
      • Maastricht, Netherlands, 6202 AZ
        • Research Site
  • Peru
      • Lima, Peru, 15033
        • Research Site
      • Lima, Peru, L27
        • Research Site
      • Lima, Peru, Lima 34
        • Research Site
      • Lima, Peru, LIMA 01
        • Research Site
      • Lima, Peru, LIMA 29
        • Research Site
      • Lima, Peru, LIMA 11
        • Research Site
      • Lima, Peru, 15073
        • Research Site
      • Miraflores, Peru, 15046
        • Research Site
  • Poland
      • Brzozów, Poland, 36-200
        • Research Site
      • Bydgoszcz, Poland, 85-796
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Gdansk, Poland, 80-219
        • Research Site
      • Grudziądz, Poland, 86-300
        • Research Site
      • Krakow, Poland, 31-202
        • Research Site
      • Lubin, Poland, 59-301
        • Research Site
      • Olsztyn, Poland, 10-357
        • Research Site
      • Opole, Poland, 45-061
        • Research Site
      • Sucha Beskidzka, Poland, 34-200
        • Research Site
      • Szczecin, Poland, 70-891
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • Research Site
      • Coimbra, Portugal, 3040-316
        • Research Site
      • Lisbon, Portugal, 1769-001
        • Research Site
      • Lisbon, Portugal, 1099-023
        • Research Site
      • Porto, Portugal, 4200-319
        • Research Site
      • Porto, Portugal, 4100-180
        • Research Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Research Site
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Research Site
      • Cluj-Napoca, Romania, 400058
        • Research Site
  • Russia
      • Kazan', Russia, 420012
        • Research Site
      • Moscow, Russia, 115478
        • Research Site
      • Moscow, Russia, 105229
        • Research Site
      • Saint Petersburg, Russia, 197758
        • Research Site
      • Saint Petersburg, Russia, 194291
        • Research Site
      • Saint Petersburg, Russia, 197342
        • Research Site
      • Volgograd, Russia, 400138
        • Research Site
  • Spain
      • Barcelona, Spain, 08003
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 08035
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Vigo(Pontevedra), Spain, 36204
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Sweden
      • Linköping, Sweden, 581 85
        • Research Site
      • Uppsala, Sweden, SE-751 85
        • Research Site
      • Örebro, Sweden, 701 85
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Research Site
      • Ankara, Turkey (Türkiye), 06280
        • Research Site
      • Istanbul, Turkey (Türkiye), 34662
        • Research Site
      • Istanbul, Turkey (Türkiye), 34844
        • Research Site
      • Izmir, Turkey (Türkiye), 35100
        • Research Site
      • Izmir, Turkey (Türkiye), 35110
        • Research Site
      • Manisa, Turkey (Türkiye), 45030
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58013
        • Research Site
      • Dnipro, Ukraine, 49102
        • Research Site
      • Kharkiv Region, Ukraine, 61070
        • Research Site
      • Kryvyi Rih, Ukraine, 50048
        • Research Site
      • Kyiv, Ukraine, 03115
        • Research Site
      • Sumy, Ukraine, 40022
        • Research Site
      • Uzhhorod, Ukraine, 88000
        • Research Site
      • Zaporizhzhia, Ukraine, 69040
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB2 2ZB
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
      • Danvers, Massachusetts, United States, 01923
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site
      • New York, New York, United States, 10011
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • 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)
  • 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

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 + Docetaxel
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
Drug: Selumetinib
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
Other Names:
  • AZD6244; ARRY-142886
Drug: Docetaxel
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Drug: Pegylated G-CSF
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.
Other Names:
  • Pegfilgrastim 6 mg
Experimental: Placebo + Docetaxel
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
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Drug: Pegylated G-CSF
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.
Other Names:
  • Pegfilgrastim 6 mg
Drug: Placebo
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.

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: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
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)
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 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: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)
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)
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)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Duration of Response (DoR)
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)
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)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
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)
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.
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)
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
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)
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.
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)

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 Jänne, MD, Dana-Faber Cancer Institute, USA
  • 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.
September 25, 2013

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.
June 7, 2016

Study Completion (Estimated)

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.
December 31, 2025

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).
August 29, 2013

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.
August 29, 2013

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.
September 2, 2013

Study Record Updates

Last Update Posted (Estimated)

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.
November 19, 2025

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.
November 12, 2025

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.
November 1, 2025

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.
  • D1532C00079
  • 2013-001676-38 (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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