A stage IIIb/stage IV lung cancer trial

The following information is about a clinical trial examining the treatment of non-squamous, non-small cell lung cancer (NSCLC) with a new investigational drug.

What kind of trial is this?

This lung cancer trial is a Phase III, randomized, double-blind, multicenter, placebo-controlled study. To find out more about what these terms mean and about clinical trials in general, please visit our Clinical trials section.

This lung cancer trial is investigating the effects of an investigational drug in patients who have received prior treatment for advanced, non-squamous NSCLC.

Patients in this trial will be randomly assigned to receive either:

  • The investigational drug + erlotinib. Erlotinib is the current standard of care for second-line treatment of non-squamous NSCLC.
  • A placebo + erlotinib. You can find out more about the usage of placebos in clinical trials in our Clinical trials section.

The principal goal of the trial is to examine the effect of the investigational drug on the overall survival of patients with lung cancer. An improvement in overall survival means that patients will live longer after successful treatment. How long patients remain free of cancer progression (progression-free survival) will also be measured, as well as the safety and effectiveness of the investigational drug in combination with erlotinib.

For more information you can also visit clinicaltrials.gov and enter the trial identifier number NCT01244191.

Here is some basic information about this lung cancer trial and how to learn more at clinicaltrials.gov.

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Where is this trial taking place?

This clinical trial is being conducted at more than 150 clinical trial locations in the U.S., Canada, Eastern and Western Europe, Australia and Latin America and will include about 1000 patients. 

It is sponsored by Daiichi Sankyo and ArQule and is being conducted in order to generate the data required for the European Medicines Agency (EMA) and Food and Drug Administration (FDA) to evaluate the safety and effectiveness of a new investigational drug.

For more information you can also visit clinicaltrials.gov and enter the trial identifier number NCT01244191. 

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Where can I find more information?

This lung cancer trial is registered at clinicaltrials.gov under the trial identifier number NCT01244191. There you will find a detailed description of the study design.

You can also learn more about this trial from your doctor.

Visit clinicaltrials.gov and enter the clinical trial identifier NCT01244191.

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Written by medical writers Claudia Sarkady and Darlene Grzegorski

Last updated: 25 July 2011

Sources: http://clinicaltrials.gov/ct2/show/NCT01244191