U.S. cancer researchers plan to launch a five-drug clinical trial for patients with advanced lung cancer in mid-May, in a public-private collaboration between several major cancer organizations and five pharmaceutical companies that marks the second American multi-drug research program into personalized medicines to treat different cancers.
Known as the lung master protocol or simply Lung-MAP trial, the proposed drugs will be tested on 500 to 1,000 patients chosen based on their genetic profiles. Once the genetics of each patient’s tumor is identified and matched to one of the drugs, patients will enter a randomized, control sub-study, with one arm receiving the leading chemotherapy drug and the other the experimental medication. However, one of the five drugs, an immune therapy medication, will be given to patients whose genetic profile is not matched to one of the other four drugs.
The trial, which will use the relatively new National Cancer Institute central IRB, involves the collaboration of the NCI, SWOG Cancer Research Center, Friends of Cancer Research and the Foundation for the National Institute of Health. Amgen, Genentech, Pfizer, AstraZeneca and its global biologics R&D arm MedImmune are the five biopharmaceutical companies. Foundation Medicine is providing the screening platform for the trial.
The Lung-MAP trial will launch a few months before a similar but larger cancer trial led by Cancer Research U.K. working with Astra Zeneca, MedImmune and Pfizer (see CenterWatch News Online, Friday, April 18). The 14-drug British study, announced last week, is slated to begin this summer. The goals of both personalized medicine trials are to change how cancer drugs are studied and potentially cut the time and cost to bring them to market.
However, one key difference is that the U.K. trial does not have a follow-up, randomized trial component. Both studies will look for signs of improvement including survival, tumor shrinkage or an alleviation of symptoms.
“This is a new way of thinking and a new model for clinical trial development,” said Ryan H. Hohman, managing director, policy and public affairs at Friends of Cancer Research, a think tank and advocacy organization that develops partnerships with both public and private sectors to conquer cancer. “The FDA and all of the partners involved have been incredibly collaborative throughout this process. This partnership has been a great experience learning to navigate how multiple public and private entities can design a protocol and really revamp how clinical trials moving forward are conducted.”
Hohman cited how aspects of the Lung-MAP and British trials are comparable to current clinical for women with newly diagnosed locally advanced breast cancer. That study is testing whether adding investigational drugs thought to target the biology of each participant’s tumor to standard chemotherapy is better than standard chemotherapy alone before having surgery. Known as the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and moLecular Analysis 2), it uses common biomarkers in breast cancer with the goal of making investigational drugs available to more women in the future.
“Aspects of this (Lung-MAP) trial and the British trial can be seen in the I-SPY 2 trial that is ongoing here in the U.S. and can be credited as really a trailblazer in this area,” said Hohman. “Our trial is taking this concept many more steps forward.”