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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

In brief

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

Key facts

Study ID: NCT01933932
Run by: AstraZeneca
People needed: 510
Starts: 2013-09-25
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Pembroke Pines, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Metairie, Louisiana, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Danvers, Massachusetts, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Durham, North Carolina, United States
Research Site — Hershey, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Nashville, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Seattle, Washington, United States
Research Site — Morgantown, West Virginia, United States
Research Site — Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Córdoba, Argentina
Research Site — Rosario, Argentina
Research Site — Camperdown, Australia
Research Site — Chermside, Australia
Research Site — Darlinghurst, Australia
Research Site — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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