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Precision Lung Cancer Trial Expands Scope

Lung cancer illustration

(NIH.gov)

30 Jan. 2019. A large-scale clinical trial testing immunotherapy drugs to treat specific types of lung cancer is expanding to include all of the most common forms of the disease. The Lung Cancer Master Protocol, or Lung-MAP trial now includes patients with all types of advanced-stage non-small cell lung cancers, covering some 85 percent of cases, as well as adding a new type of drug and diagnostic processes to the study.

The Lung-MAP trial up to now recruited patients with squamous cell lung cancer in its advanced stages. Squamous cell lung cancer affects squamous cells lining the lungs and accounts for 25 to 30 percent of all lung cancers, according to American Cancer Society. The study now is enrolling patients with all types of advanced-stage non-small cell lung cancers, a group of cancer types affecting various cells in the lungs, but having similar treatments and outlooks. Squamous cell lung cancer is one type of non-small cell lung cancer.

This project is actually a collection of clinical trials that aims to recruit 10,000 participants with advanced-stage lung cancer, meaning the cancer spread or metastasized to other parts of the body. Individuals enrolled are first tested for the presence of 200 genetic mutations associated with cancer in their DNA, with those results helping guide the type of immunotherapy treatment received. The overall conduct of the trial is governed by a master protocol, or common set of rules, where  a single trial design is used to test a series of precision-medicine treatments. In September 2018, Science & Enterprise reported on the I-SPY2 clinical trial also employing a master protocol to test precision medicine treatments of breast cancer.

“We have more than 200,000 new cases of non-small cell lung cancer in the United States each year, and we desperately need new treatments,” says Vali Papadimitrakopoulou, chief of thoracic medical oncology at University of Texas MD Anderson Cancer Center and the study’s principal investigator in a Southwest Oncology Group statement. “When most people are diagnosed with non-small cell lung cancer, their cancer has already grown and spread to other organs. If standard therapies don’t work for these patients, and often they don’t, they need alternatives. Lung-MAP provides those alternatives.” Southwest Oncology Group is conducting the Lung-MAP project, funded by National Cancer Institute, part of National Institutes of Health.

In addition to expanding the scope of the project, Lung-MAP is adding liquid biopsies that make it easier to diagnose the cancer’s presence and progression. Liquid biopsies are blood tests that indicate the presence of tumor cells in the samples, which are much less invasive than lung tissue biopsies requiring surgery. Liquid biopsies also make it easier to track changes in the patient’s cancer, which previously required tissue samples as well.

The Lung-MAP trial is also adding a new type of drug for testing. The drugs are known as poly (ADP-ribose) polymerase or PARP inhibitors that block DNA-repairing enzymes from working. While repairing damaged DNA may seem like a good thing, in treating cancer, PARP inhibitors can block cancer cells from repairing damaged, but mutated DNA supporting cancer proliferation, thus helping cancer drugs work more effectively.

The project as well is taking new steps to speed up its processes, including a streamlined informed consent form that combines screening and pre-screening, as well as a requirement to use the National Cancer Institute’s central institutional review board to oversee any changes in the trial, rather than coordinating the changes among separate local boards.

Since its start in June 2014, Lung-MAP enrolled some 1,800 participants at 650 sites. Foundation Medicine in New York conducts the genetic analysis to screen patients, and 10 pharmaceutical companies provide immunotherapy drugs for testing.

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