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Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network

18 Years
Open (Enrolling)
Non-small Cell Lung Cancer Metastatic, Small Cell Lung Carcinoma

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Trial Information

Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network

Because of the historically poor outcomes of lung cancer patients, suboptimal therapeutic
efficacy, and significant side effects of chemotherapy, and the need to choose more
efficacious treatment regimens, and patients most likely to benefit from them, there is a
need to predict a priori whether an individual patient's tumor will respond to a particular
therapeutic agent. However, virtually all lung cancer tumor samples available today are from
resection specimens so direct, intra-patient molecular-clinical therapy correlations are

Without the critical mass of tissue and data necessary to identify optimal molecular targets
for lung cancer and drugs active against these targets, new discoveries that offer the only
hope of long-term survival for many lung cancer patients remain elusive.

This study facilitates the collection of biospecimens from advanced lung cancer patients and
routine determination of a panel of documented clinically significant biomarkers. In
addition, it will centrally integrate and standardize research tissue samples with
corresponding proteomic, genomic, molecular and clinical data across a multitude of
institutions and oncology networks

Inclusion Criteria:

- M1A or B NSCLC with any number of prior therapies 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

- Aged 18 years and over.

- Measurable or evaluable disease.

- ECOG performance status of 0-2 with expected survival of at least 3 months.

- Tumor specimens:

- Tumor specimens:

- 4.7.1 First Priority: availability of a minimum of a 1 X 10 mm core fresh frozen
tumor, or ≥3 mm diameter spherical pellet from a pleural effusion (≥50% tumor cells),
or ≥3 mm diameter spherical pellet from a fine needle aspirate (≥50% tumor cells)
from clinically indicated interventional procedures, with no systemic anti-cancer
therapy or radiation to all sites of evaluable disease between collection of the
biopsy and entry into the study (e.g. if a brain metastasis was radiated but the lung
tumor was not, then the latter could still be biopsied and the subject enrolled after
radiation therapy of the brain metastasis (and vice versa)).


- Second Priority: availability of paraffin-embedded tumor (via biopsies or pleural
effusions) at least 5 X 5 mm (3 X 3 mm for pleural effusions) cross-sectional tumor
area, with no systemic anti-cancer therapy or radiation to all sites of evaluable
disease between collection of the biopsy and entry into the study; the collection of
the paraffin-embedded tissues may have taken place up to 12 months prior to
enrollment in CASTLE.

- Willingness to undergo all study collection procedures and sample analyses including
prerequisite baseline molecular testing via ResponseDX: Lung (Response Genetics Inc.)
and VeriStrat (Biodesix) - see 6.3 below for details.

- Exclusion criteria

- Other co-existing malignancies except for basal cell carcinoma or cervical cancer in

- Compromise of patient diagnosis or staging if tissue is harvested for research

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients

Outcome Time Frame:

7 years

Safety Issue:


Principal Investigator

Leora Horn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Institutional Review Board

Study ID:

THO 09110



Start Date:

November 2010

Completion Date:

January 2017

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Small Cell Lung Carcinoma
  • Small Cell Lung Cancer (SCLC)
  • Non-Small Cell Lung Cancer (NSCLC)
  • M1A or B NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Neoplasms
  • Neoplasms, Second Primary



Hoag Memorial Hospital Presbyterian Newport Beach, California  92658
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University of California, Los Angeles Los Angeles, California  
Memorial Cancer Institute Pembroke Pines, Florida  33028
University of California, Davis Cancer Center Sacramento, California  95817
Alta Bates Summit Medical Center, The Jordan Research and Educational Institute Berkley, California  94705
University of California, Norris Comprehensive Cancer Center Los Angeles, California  90033
University of California, Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Lahey Clinic Hospital Burlington, Massachusetts  01805