The cancer research community is moving forward in its efforts find more effective treatment for patients with lung cancer. Current clinical trials are taking innovative approaches to how therapies for both advanced and early-stage lung cancers are studied. The goal of each study is to improve access to promising drugs for patients with more efficient clinical trials processes.
These two trials include the Lung Cancer Master Protocol (Lung-MAP) trial and the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST). Lung-MAP is studying therapy for advanced NSCLC and the ALCHEMIST trials are studying treatment in early-stage disease. (1,2)
The Lung-Map Trial
Lung-MAP is the first large-scale precision medicine trial in lung cancer backed by the NCI and the first major NCI cancer trial to test multiple treatments, simultaneously, under one “umbrella” design emphasizing the importance of genomic and biomarker testing in the management of NSCLC.(3)
Lung-MAP key changes announced 1/2019 include:
• A new screening protocol to include the addition of liquid biopsies, as well as a streamlined informed consent form that combines screening and pre-screening — a step that will make it easier to enroll patients.
• One new drug sub-study, testing a PARP inhibitor was added.
The ALCHEMIST Lung Cancer Trials
The ALCHEMIST trials include three clinical trials for patients with certain types of early-stage non-small cell lung cancer (NSCLC) that has been treated surgically. The trials will study targeted therapies that have been approved for advanced lung cancer but are currently not approved for treatment of patients with early-stage disease.
Each participant will be matched with the targeted therapy most likely to work for them. In the screening component of the ALCHEMIST trials, researchers will screen tumor samples for specific genetic mutations (abnormalities in the DNA sequence of a cell that are passed from parents to children) that may be involved in the development of cancer. Once specific mutations are identified, these early-stage NSCLC patients will be assigned to one of two different treatment arms, where they’ll receive drugs approved to target their mutation in advanced lung cancer. The ALCHEMIST trials will assess whether these treatments are safe and effective in early-stage NSCLC that has been surgically removed.
Researchers will look for genetic mutations in two genes thought to drive cancer growth, ALK and EGFR. Therapies are available that target both of these mutations. Patients who have one of these alterations will then be referred to one of the two treatment trials. One study is evaluating the drugs Xalkori® (crizotinib) and the other Tarceva® (erlotinib)—both as treatment after surgery for patients with early-stage NSCLC. Patients will be monitored for recurrence and survival.
Researchers with the ALCHEMIST trials hope that identifying genetic mutations in early-stage lung cancer patients and treating them with the appropriate targeted therapies will help more patients get effective treatment.
More information on each component of the ALCHEMIST trials is available at:
- Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network [press release]. The National Cancer Institute. Available at: http://www.cancer.gov/newscenter/newsfromnci/2014/LungMAPlaunch. Accessed December 19, 2014.
- The ALCHEMIST Lung Cancer Trials. The National Cancer Institute website. Available at: http://www.cancer.gov/clinicaltrials/noteworthy-trials/alchemist. Accessed December 19, 2014.