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

Completed · Phase 2 · 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 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

Key facts

Study ID

NCT01750281

Run by

AstraZeneca

People needed

212

Starts

2012-12-18

Expected to finish

2022-10-31

Last updated by the study team

2023-10-24

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)
• 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

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.
• 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.

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Marrero, Louisiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Mineola, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Barretos, Brazil
• Research Site — Brasília, Brazil
• Research Site — Ijuí, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Santo André, Brazil
• Research Site — São José do Rio Preto, Brazil
• Research Site — São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Plovdiv, Bulgaria
• Research Site — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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