Two groundbreaking collaborative lung cancer trials that employ novel and more efficient models of study design are set to enroll patients.
The US-based Lung Cancer Master Protocol (Lung-MAP) trial is seeking patients with advanced squamous cell lung cancer (SCLC) and the Cancer Research UK National Lung Matrix Trial is recruiting patients with stage 3b or later non-small cell lung cancer (NSCLC). Both trials are sponsored by multiple sources, are biomarker-driven, and will use both experimental and currently available drugs.
The goal of these trials is to reduce the burden that traditional clinical trial design imposes on investigators, patients, and drug manufacturers by streamlining all aspects of the process.
Lung-MAP is the first precision medicine trial from the National Cancer Institute’s newly formed National Clinical Trials Network (NCTN). Led by the Southwest Oncology Group (SWOG), the study is testing four targeted therapies and an anti-PD-L1 immunotherapeutic agent at more than 200 medical centers nationwide.1
The trial will annually screen 500 to 1,000 patients with SCLC who have completed one course of chemotherapy for their cancer for more than 200 cancer-related genomic alterations. Genomic profiling will then be used to assign each patient to one of five trial arms, which in turn has two arms. For example, if tumor DNA harbors a PIK3CA gene mutation, the patient will be randomly assigned to receive chemotherapy or the experimental agent GDC0032 (Genentech). Other agents being tested are MED14736 (MedImmune), palbociclib (Pfizer), AZD4547 (AstraZeneca), erlotinib (Genentech and Astellas Oncology), and rilotumumab (Amgen).
As many as five to seven additional drugs will be tested over the next 5 years. The flexible “master protocol” design allows amendments as drugs enter and exit, avoiding the necessity for a new protocol for each new agent tested. “If a drug meets predetermined efficacy and safety criteria, the drug and its accompanying diagnostic biomarkers will be eligible for U.S. Food and Drug Administration (FDA) approval,” according to the Lung-MAP website.
Lung-MAP represents a public–private collaboration among the National Cancer Institute, SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), Amgen, Genentech, Pfizer, AstraZeneca, MedImmune (AstraZeneca’s global biologics R&D arm), and Foundation Medicine.
Trials costs are estimated at $160 million. The trial is partly funded by the National Cancer Institute through its Cancer Therapy Evaluation Program, with additional funding from the participating companies as part of a partnership managed by FNIH that also involves the FDA, Friends of Cancer Research, and other patient advocacy organizations.
For more information, visit http://www.lung-map.org/.
Cancer Research UK National Lung Matrix Trial
The National Lung Matrix Trial will be conducted via Cancer Research UK’s Experimental Cancer Medicine Centre (ECMC) network of 18 centers. The total number of patients enrolled is not fixed but will evolve as new drugs become available. Initially, up to 14 drugs are being investigated; each in approximately 15 to 20 patients.2
The trial is sponsored and coordinated by the Birmingham Cancer Research Clinical Trials Unit, with patient recruitment, care, and treatment headed by the local ECMC, allowing the trial to be brought to the patient.
The trial cost of £25 million ($42.8 million) is being jointly funded by Cancer Research UK, AstraZeneca, and Pfizer, with support from the National Health Service. Up to 14 agents may be included, 12 from AstraZeneca/MedImmune, and two from Pfizer (crizotinib and palbociclib) according to a Pfizer spokesperson.
- National Cancer Institute at the National Institutes of Health. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network. http://www.cancer.gov/newscenter/newsfromnci/2014/LungMAPlaunch. Published June 16, 2014. Accessed July 1, 2014.
- Cancer Research UK. Revolutionary clinical trial aims to advance lung cancer treatment thanks to Cancer Research UK and Pharma partnership. http://www.cancerresearchuk.org/about-us/cancer-news/press-release/revolutionary-clinical-trial-aims-to-advance-lung-cancer-treatment-thanks-to-cancer-research-uk-and. Published April 17, 2014. Accessed June 30, 2014.