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

NCT01933932 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2013-09-25

Last updated

2026-07-21

Condition(s) studied

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

Investigational drug(s) / intervention(s)

SelumetinibDocetaxelPlaceboPegylated G-CSF

Selumetinib: Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.

Docetaxel: Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

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.

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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

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

Primary outcome measure(s)

Progression-Free Survival (PFS) — 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)

Trial sites (197)

Facility	City	Region
Research Site	Aurora	Colorado
Research Site	Pembroke Pines	Florida
Research Site	Atlanta	Georgia
Research Site	Chicago	Illinois
Research Site	Metairie	Louisiana
Research Site	Boston	Massachusetts
Research Site	Boston	Massachusetts
Research Site	Danvers	Massachusetts
Research Site	New York	New York
Research Site	New York	New York
Research Site	Durham	North Carolina
Research Site	Hershey	Pennsylvania
Research Site	Philadelphia	Pennsylvania
Research Site	Nashville	Tennessee
Research Site	Nashville	Tennessee
Research Site	Seattle	Washington
Research Site	Morgantown	West Virginia
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	Fitzroy	Australia
Research Site	Kogarah	Australia
Research Site	Kurralta Park	Australia
Research Site	Malvern	Australia
Research Site	Wendouree	Australia
Research Site	Woodville South	Australia
Research Site	Innsbruck	Austria
Research Site	Linz	Austria
Research Site	Salzburg	Austria
Research Site	Vienna	Austria
Research Site	Vienna	Austria
Research Site	Brussels	Belgium
Research Site	Brussels	Belgium
Research Site	Brussels	Belgium
Research Site	Ghent	Belgium

+ 157 more sites — see the full list on the official registry below.

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A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01933932 on ClinicalTrials.gov ↗ ← All trials in the UK