Active Not RecruitingPhase 3NCT01933932

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

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

Checked against the public recordLast updated Jul 21, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations197
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: Selumetinib; Drug: Docetaxel; Drug: Placebo; Drug: Pegylated G-CSF
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteAurora, Colorado
  • Research SitePembroke Pines, Florida
  • Research SiteAtlanta, Georgia
  • Research SiteChicago, Illinois
  • Research SiteMetairie, Louisiana
  • Research SiteBoston, Massachusetts
  • Research SiteBoston, Massachusetts
  • Research SiteDanvers, Massachusetts
  • Research SiteNew York, New York
  • Research SiteNew York, New York
  • Research SiteDurham, North Carolina
  • Research SiteHershey, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2026. Always confirm current availability with the study team.

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