In the Bay Area in San Francisco and around the country, there is a new type of clinical trials for lung cancer patients underway at hospitals.

The study is called the Lung Cancer Master Protocol, or Lung-MAP. Researchers have the bold expectation that these clinical trials will change the way drugs are tested in the future.

The Lung-MAP trials brought more than 400 medical centers, multiple oncology groups, the National Cancer Institute and other federal health agencies, pharmaceutical companies, patient advocacy groups and private foundations together.

In standard trials, one drug is tested at a time and researchers have little advanced knowledge about which patients are likely to benefit or why.

In the new trial, every patient receives a test drug based on the genomic profile of his or her tumor. The new trial involves testing five different drugs at the same time.

According to Lung-MAP collaborators, current drug testing methods no longer make sense given the changes in science and technology.

If this approach is successful, many more will follow in these steps and develop similar tests for other cancers.

The researchers that participated in the study focused on squamous cell lung cancer.

Squamous cell typically forms in the lining of the bronchial tubes. It is the second most common type of lung cancer behind the adenocarcinoma. It is diagnosed in 15-30% of lung cancer patients. It accounts for almost 225,000 new U.S. cases a year and kills more than 159,000 American annually.

The concept originated from the U.S. Food and Drug Administration and large competitive drug companies including Amgen, Genentech, Pfizer, AstraZeneca and AstraZeneca’s MedImmune.

Lung-MAP collaborators believe that the entire process will take 10 to 12 years and at least a billion dollars before making it to the drug market.

 

Gerry Oginski
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NY Medical Malpractice & Personal Injury Trial Lawyer
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