Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network (CASTLE)

• ClinicalTrials.gov Identifier: NCT01574300
• Recruitment Status: Terminated
• First Posted: April 10, 2012
• Last Update Posted: January 10, 2020
• Sponsor: Addario Lung Cancer Medical Institute
• Information provided by (Responsible Party): Addario Lung Cancer Medical Institute

Tracking Information

• First Submitted Date: March 28, 2012
• First Posted Date: April 10, 2012
• Last Update Posted Date: January 10, 2020
• Study Start Date: November 2010
• Actual Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 9, 2012): Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients [ Time Frame: 7 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 9, 2012)

• Maintain a centralized, computerized database of all specimens [ Time Frame: 7 years ]
  Database would contain uniform and complete demographic, pathologic, and clinical information
• Facilitate integration of molecular assays and other laboratory studies with clinical patient outcomes [ Time Frame: 7 years ]
• Enable the discovery of novel genes and proteins related to cancer and its therapies [ Time Frame: 7 years ]
  Obtain funding from National Institutes of Health based on use of the biorepository

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
• Official Title: Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
• Brief Summary: The purpose of this study is to facilitate application of the known biomarkers to patients presenting today, and to establish a collection of biospecimens that will be useful for discovering and validating new biomarkers for future use.

Detailed Description

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 impossible.

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

• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Advanced stage lung cancer patients

Condition

• Non-small Cell Lung Cancer Metastatic
• Small Cell Lung Carcinoma

Intervention

Other: therapeutic interventions

All therapeutic interventions are allowed, and their details recorded and correlated with data from the collected biospecimens. Examples would include single or multiple agent chemotherapy or targeted therapeutics

Study Groups/Cohorts

Biospecimens and biofluids

This is a multi-cohort parallel study in which tumor, plasma and serum samples will be collected prior to the start of any therapeutic intervention for stage IV lung cancer. These biospecimens will be correlated with treatment and clinical data and distributed for peer reviewed research purposes to academic and community centers in the U.S. and Europe.

The biospecimens collected in CASTLE will be analyzed for a panel of biomarkers, currently including:

• tumor: epidermal growth factor receptor (EGFR), KRAS (Kirsten RAt Sarcoma) gene and EML4-ALK (echinoderm microtubule-associated protein-like 4 - anaplastic lymphoma kinase) translocations, and EGFR, TS (thymidylate synthase), ERCC1 (excision repair cross-complementing 1) and RRM1 (Ribonucleotide Reductase, M1 Subunit) gene expressions
• serum: proteomics predictive for EGFR-TKI (tyrosine kinase inhibotors)response

Intervention: Other: therapeutic interventions

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 24, 2019): 136
• Original Estimated Enrollment (submitted: April 9, 2012): 250
• Actual Study Completion Date: March 1, 2019
• Actual Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)).

or

• 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 situ.
• Compromise of patient diagnosis or staging if tissue is harvested for research

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01574300
• Other Study ID Numbers: VICC THO 09110; CASTLE Study ( Other Identifier: Adarrio Lung Cancer Institute (ALCMI) )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Addario Lung Cancer Medical Institute
• Study Sponsor: Addario Lung Cancer Medical Institute
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Addario Lung Cancer Medical Institute
• Verification Date: January 2020