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



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 127
Updated:3/30/2019
Start Date:September 25, 2013
End Date:December 31, 2019

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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)

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

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)

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
We found this trial at
16
sites
180
mi
from 02139
New York, NY
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934
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Atlanta, GA
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1755
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Aurora, CO
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2
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Boston, MA
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5378
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Buenos Aires,
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846
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Chicago, IL
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16
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from 02139
Danvers, MA
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605
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from 02139
Durham, NC
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321
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from 02139
Hershey, PA
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1358
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Metairie, LA
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498
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Morgantown, WV
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939
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from 02139
Nashville, TN
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180
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from 02139
New York, NY
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1244
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Pembroke Pines, FL
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268
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Philadelphia, PA
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2481
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from 02139
Seattle, WA
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