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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.