Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment. (SELECT-2)

AstraZeneca

Status and phase: Completed; Phase 2

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

Treatments: Drug: Placebo; Drug: Docetaxel 75 mg/m2; Drug: Selumetinib 75 mg; Drug: Docetaxel 60 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01750281

2012-003622-25 (EudraCT Number)

D1532C00064

Details and patient eligibility

About

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Full description

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

Enrollment: 212 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No 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)
• Prospective confirmation of KRAS mutation negative status as determined via an AZ approved 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.
• Other concomitant anti-cancer therapy agents except steroids
• Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
• The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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212 participants in 3 patient groups

Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2

Experimental group

Description:

Selumetinib 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.

Treatment:

Drug: Selumetinib 75 mg

Drug: Docetaxel 75 mg/m2

Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2

Experimental group

Description:

Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle.

Treatment:

Drug: Selumetinib 75 mg

Drug: Docetaxel 60 mg/m2

Placebo twice daily + Docetaxel 75 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel 75 mg/m2

Drug: Placebo