Fact CheckerSign in

NCT01933932Active, not recruitingPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
510 (actual)
First submitted
29 Aug 2013
Start date
25 Sept 2013
Primary completion date
7 Jun 2016
Lead sponsor
AstraZeneca
NCT number
NCT01933932
EudraCT number
2013-001676-38

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 510
  • From 25 Sept 2013 to the primary completion date, 7 Jun 2016
  • 159 sites in 26 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Mixed small cell and non-small cell lung cancer histology.

Who the study is looking for

  • 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

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (159)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Site
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Research Site
Coordinator of this site? Confirm its status
Ciudad de Buenos AiresArgentinaUnknown status
Research Site
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Research Site
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Research Site
Coordinator of this site? Confirm its status
InnsbruckAustriaUnknown status
Research Site
Coordinator of this site? Confirm its status
LinzAustriaUnknown status
Research Site
Coordinator of this site? Confirm its status
SalzburgAustriaUnknown status
Research Site
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Research Site
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
ChermsideAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
KogarahAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
Kurralta ParkAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
MalvernAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
WendoureeAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
Woodville SouthAustraliaUnknown status
Research Site
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Research Site
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
Research Site
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Research Site
Coordinator of this site? Confirm its status
RoeselareBelgiumUnknown status
Research Site
Coordinator of this site? Confirm its status
PlovdivBulgariaUnknown status
Research Site
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Research Site
Coordinator of this site? Confirm its status
VarnaBulgariaUnknown status
Research Site
Coordinator of this site? Confirm its status
VratsaBulgariaUnknown status
Research Site
Coordinator of this site? Confirm its status
BarretosBrazilUnknown status
Research Site
Coordinator of this site? Confirm its status
IjuíBrazilUnknown status
Research Site
Coordinator of this site? Confirm its status
PelotasBrazilUnknown status
Research Site
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Research Site
Coordinator of this site? Confirm its status
São José do Rio PretoBrazilUnknown status
Research Site
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Research Site
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
OshawaCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
ReginaCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
SaskatoonCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
SurreyCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Research Site
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Research Site
Coordinator of this site? Confirm its status
AugsburgGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
Bad BerkaGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
DortmundGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
GerlingenGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
GroßhansdorfGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
HalleGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
HomburgGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
LöwensteinGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
MoersGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
MünchenGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
UlmGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
WiesbadenGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
WürzburgGermanyUnknown status
Research Site
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Research Site
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Research Site
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Research Site
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Research Site
Coordinator of this site? Confirm its status
Vigo (Pontevedra)SpainUnknown status
Research Site
Coordinator of this site? Confirm its status
ZaragozaSpainUnknown status
Research Site
Coordinator of this site? Confirm its status
BrestFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
CaenFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
DijonFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
Pierre-BéniteFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
RennesFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Research Site
Coordinator of this site? Confirm its status
AberdeenUnited KingdomUnknown status
Research Site
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Research Site
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Research Site
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
Research Site
Coordinator of this site? Confirm its status
SuttonUnited KingdomUnknown status
Research Site
Coordinator of this site? Confirm its status
WolverhamptonUnited KingdomUnknown status
Research Site
Coordinator of this site? Confirm its status
BudapestHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
EdelényHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
GyőrHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
KaposvárHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
MiskolcHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
NyíregyházaHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
TörökbálintHungaryUnknown status
Research Site
Coordinator of this site? Confirm its status
BeershebaIsraelUnknown status
Research Site
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Research Site
Coordinator of this site? Confirm its status
Kfar SabaIsraelUnknown status
Research Site
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Research Site
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Research Site
Coordinator of this site? Confirm its status
Tel HaShomerIsraelUnknown status
Research Site
Coordinator of this site? Confirm its status
BariItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
GenovaItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
LivornoItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
OrbassanoItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
ParmaItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
PerugiaItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Research Site
Coordinator of this site? Confirm its status
MéxicoMexicoUnknown status
Research Site
Coordinator of this site? Confirm its status
MonterreyMexicoUnknown status
Research Site
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Research Site
Coordinator of this site? Confirm its status
Bergen op ZoomNetherlandsUnknown status
Research Site
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Research Site
Coordinator of this site? Confirm its status
's-HertogenboschNetherlandsUnknown status
Research Site
Coordinator of this site? Confirm its status
LimaPeruUnknown status
Research Site
Coordinator of this site? Confirm its status
MirafloresPeruUnknown status
Research Site
Coordinator of this site? Confirm its status
BrzozówPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
BydgoszczPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
GdanskPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
GrudziądzPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
KrakowPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
LubinPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
OlsztynPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
OpolePolandUnknown status
Research Site
Coordinator of this site? Confirm its status
Sucha BeskidzkaPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
SzczecinPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
Research Site
Coordinator of this site? Confirm its status
AmadoraPortugalUnknown status
Research Site
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status
Research Site
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Research Site
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Research Site
Coordinator of this site? Confirm its status
Vila Nova de GaiaPortugalUnknown status
Research Site
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaUnknown status
Research Site
Coordinator of this site? Confirm its status
Kazan'RussiaUnknown status
Research Site
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Research Site
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Research Site
Coordinator of this site? Confirm its status
VolgogradRussiaUnknown status
Research Site
Coordinator of this site? Confirm its status
LinköpingSwedenUnknown status
Research Site
Coordinator of this site? Confirm its status
ÖrebroSwedenUnknown status
Research Site
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status
Research Site
Coordinator of this site? Confirm its status
ChernivtsіUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
DniproUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
Kharkiv RegionUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
Kryvyi RihUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
SumyUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
UzhhorodUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
ZaporizhzhyaUkraineUnknown status
Research Site
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
DanversUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
HersheyUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
MetairieUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
MorgantownUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
Pembroke PinesUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Research Site
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Research Site
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
Research Site
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status
Research Site
Coordinator of this site? Confirm its status
ManisaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.