Dana-Farber to Lead Early-Stage Lung Cancer Trial

Reps for Dana-Farber are calling the trial ‘ambitious.’

There’s two molecularly targeted drugs that have already been shown to improve outcomes in advanced lung cancer patients. Now, the National Cancer Institute (NCI) wants to see if these same drugs can increase the survival odds of patients with early-stage lung cancer that has been surgically removed. The two drugs will be tested for use through a new clinical trial that will be spearheaded at Dana-Farber Cancer Institute.

According to Dana-Farber, more than half of lung cancer patients experience recurrences of the disease, even if it was completely removed, because “tiny clumps of cancer cells invisible to the surgeon metastasize through the blood vessels to cause new cancers.”

The “ambitious new nationwide clinical trial” will investigate, according to reps for Dana-Farber, the potential survival benefit of the targeted drugs, each patient’s lung cancer risk characteristics, and will analyze tumor specimens when patients relapse to determine how their tumors become resistant to treatment.

According to a report by Dana-Farber:

Dana-Farber Cancer Institute researchers are leading the screening phase of the trial, in which 6,000 to 8,000 patients will have their tumors tested for uncommon genetic alterations that are associated with improved response to targeted cancer drugs. Those who have the alterations will randomly receive either a targeted drug or a placebo, and all patients will be followed for 5 years to determine if the drug treatment prolongs survival.

The opening of the clinical trial, called ALCHEMIST (an acronym for the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials), was announced Monday by the NCI. Patients will be recruited at multiple centers across the country over the next five or six years. To be eligible, patients “must already have had surgery to completely remove their lung tumors, and must have completed any adjuvant (follow-up) treatment such as chemotherapy and radiation.”

“We are excited to participate in this ambitious undertaking,” said Geoffrey Oxnard, MD, a researcher at Dana-Farber who will be leading the trial. “Through this large-scale collaborative effort to genotype thousands of early-stage lung cancer patients, ALCHEMIST allows us to test better adjuvant treatments while simultaneously teaching us important lessons about the genetic complexity of lung cancer.”

According to the report:

Patients found to have EGFR mutations in their tumors will be referred to a trial of the drug erlotinib (commercial name Tarceva®), while those with ALK mutations will enter a separate trial of treatment with crizotinib (Xalkori®). In each trial, patients will be randomized to the drug or a placebo. Trial leaders expect about 800 patients to receive a drug or placebo in the two treatment trials. All patients will be followed for five years, including the large number of patients who will be found to lack either mutation.

One of the genetic alterations, in the EGFR gene, is found in about 10 percent of patients with adenocarcinoma of the lung, and five percent have an alteration in the ALK gene.

Although the Food and Drug Administration has approved erlotinib and crizotinib for treatment of advanced lung cancer, it’s not known whether the drugs will be effective in patients who have undergone complete removal of lung tumors with one of the mutations.

For more information, visit dana-farber.org.