Research Initiatives

ALCMI is already helping to revolutionize the current standard of care for lung cancer patients through our inaugural collaborative research project - Collaborative Advanced Stage Tissue Lung Cancer Network - termed CASTLE. This clinical trial was launched in November 2010 and is collecting tumor tissues, blood and clinical data from advanced stage lung cancer patients. ALCMI offers this one-of-a-kind research resource for investigators around the globe.

The CASTLE Network study is open in the United States and will be opening in Europe in 2012.

  • Adults, aged 18 years and over, diagnosed with M1A or B Non Small Cell Lung Cancer (NSCLC) or any stage Small cell Lung Cancer (SCLC) with any number of prior therapies.
  • Planned systemic therapy (i.e. intent to treat).
  • Provision of written informed consent for biospecimen storage, broad genetic and proteomic analysis of tumor and normal tissues, without restrictions, AND correlation with outcome data.
  • Measurable or evaluable disease.
  • ECOG performance status of 0-2 with expected survival of at least 3 months.
  • Availability of tumor specimens:
  • Willingness to undergo prerequisite baseline molecular testing via ResponseDX: Lung (Response Genetics Inc.) and VeriStrat (Biodesix).
  • At therapeutic decision points, highly annotated, prospective tumor and blood samples are collected

    • Enrolled subjects are followed throughout their lifetime or for as long as they decide to participate in the study

    • A Biorepository of DNA, RNA and proteins will be linked with patient outcomes data via web-based tools

    CASTLE provides a broad-based, clinically validated panel of biomarkers and partnerships with diagnostic laboratories

    • A dynamic biomarker panel is evolving

    • Tissue collections will enable reanalysis as new molecular markers and mutations are discovered

    CASTLE bridges the gap

    • CASTLE provides immediate access to technologies, information and data to treating physicians and community health providers leading to better outcomes for patients via customized treatment – consequently treat the whole person rather than just the disease

    • CASTLE will have a registry of tissue like no other in the world, available no only to investigator in the United States, but worldwide.

    What happens if you join this study?
    You will meet with a lung cancer doctor who is an ALCMI CASTLE study doctor, and members of his or her research team. They will explain the study.

    If you agree to participate in the study, the procedures are as follows:

    • You will be asked to give samples from a biopsy (a tissue sample from your tumor). You will be asked to participate in this study only if you have already had a biopsy, or are having a planned biopsy or surgery. You will not be asked to have a biopsy or surgery only to qualify for or participate in this study.

    • At study entry, you will be asked about your health and cancer history, current medications, smoking history, toxic exposure history, and your family history of cancer. You will also be asked to give about 36 milliliters, or a little more than 7 teaspoons, of blood for testing and research. This visit will take about one hour to complete.

    • Every time there are changes in your lung cancer treatments you will be asked to give about 19 milliliters, or almost 4 teaspoons, of blood for research purposes. You will also be asked about your current and recent medications, and any cancer treatments at these visits. Each visit will take about 30 minutes to complete.

    • You will be asked to give your study doctor and his or her research team permission to contact you or your family every 3 months and/or if your cancer treatment changes. They will ask you about your health and your treatment.

    Alta Bates Summit Medical Center
    Oakland, California
    Contact: Margie Macarewich, RN, MSN

    Hoag Memorial Hospital
    Newport Beach, California
    Contact: Douglas R. Zusman, MD

    Lahey Clinic Hospital
    Burlington, Massachusetts
    Contact: Kathleen Sherman
    Clinical Research Associate

    Vanderbilt University
    Nashville, Tennessee
    Contact: David P. Carbone, MD, PhD

    University of California, Davis
    Sacramento, California
    Contact: Corinne Turrell
    Clinical Trials Navigator

    Contact: Grace Loredo
    Sr. Clinical Research Coordinator

    University of California, San Francisco
    San Francisco, California
    Contact: Scot Hammond

    University of Southern California
    Los Angeles, California
    Contact: Gina Tse, RN
    Protocol Coordinator, 323-865-0514

    Correlative science is a term used to show the relationship between molecular biology (i.e. biomarkers such as genes and proteins) and clinical outcomes (i.e. disease progression). This is the promise of personalized medicine.

    ALCMI is currently developing a new correlative study enabling longitudinal detection and monitoring of mutations in blood and correlation with clinical outcomes in lung cancer patients. In certain subsets of patients, we will determine whether the existing or acquired resistance mutations can be identified in the blood of patients at study entry and prospectively over time. Further, we will describe the treatment, clinical course and overall clinical outcome in patients with detectable mutations compared to those in which it is not detected.

    Evaluating the prevalence and prognostic value of certain lung cancer related biomarkers (expression, mutation, methylation, proteins) in samples from patients enrolled in observational biomarker and therapeutic clinical trials to establish a translational biomarker database. The resultant data are analyzed in the context of (1) known clinico-pathological variables, (2) clinical prognosis and outcome in lung cancer patients, and (3) additional disease-specific biomarkers that have been profiled by ALCMI’s academic collaborators and biopharmaceutical partners. The results of these studies will help to guide clinical study designs as well as inform physicians and patients of the genetics and biology of their particular tumors.