Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/27/2017
Start Date:April 4, 2016
End Date:December 2020
Contact:Niki Givens, B.S.
Email:niki.givens@biodesix.com
Phone:720-495-1583

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An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects With Non-Small Cell Lung Cancer

The purpose of this study is to collect information about how a doctor uses the results of
the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients.
Understanding how VeriStrat test results influence doctors' decisions and patients' outcomes
may help doctors to better treat NSCLC in the future. This study will also look to establish
whether new investigational tests can help better predict the effectiveness of certain
medications for certain patients. These new investigational tests are only for research
purposes at this time.

The primary purpose of this observational study is to assess the physician's clinical
practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are
epidermal growth factor receptor (EGFR) wild-type (negative) or have unknown EGFR mutational
status. This study will also attempt to further validate that VeriStrat test results stratify
subjects by clinical outcomes in the real world, uncontrolled clinical setting while
exploring whether certain therapeutic approaches may yield opportunities for further study.

Predictive tests that aid physician therapeutic decision making are critical for optimizing
subject outcomes while minimizing toxicity and associated treatment costs. This study will
provide data for the validation of immunotherapy tests currently being developed.
Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor
microenvironment, and the patient immune system. As such, a successful predictive test will
reflect the complex interplay between tumor and host. The multivariate tests from Biodesix
have the advantage of being able to assess this complex biology.

The information gained from this research will not only guide the adoption of the VeriStrat
test and inform medical decision making, including treatment choice, but will allow the
validation of additional mass-spectrometry-based proteomic tests.

Inclusion Criteria:

1. Subject must be 18 years of age or older at time of signing informed consent form
(ICF).

2. A diagnosis of NSCLC.

3. EGFR mutation status wildtype or unknown.

4. Subject is willing to provide serum samples for VeriStrat testing.

5. For subjects with UNKNOWN EGFR status only: The subject must be willing to provide
plasma samples for GeneStrat testing.

6. Subject is willing to provide serum samples for research, understanding that no test
results will be made available either to the subject or the treating physician.

7. If subject has had prior treatment for local disease, disease progression was
documented and treatment was completed prior to VeriStrat testing.

8. Subject is able to read and understand the ICF, and agrees to comply with study
procedures and requirements.

Exclusion Criteria:

1. History of prior malignancy within 2 years of signing ICF (except for adequately
treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix,
superficial bladder cancer, or early stage prostate cancer, without evidence of
recurrence).

2. Subject's ability to understand the requirements of the protocol or to provide
informed consent is impaired or subject is unwilling to comply with the protocol
requirements.
We found this trial at
28
sites
330 Washington St #220
Norwich, Connecticut 06360
(860) 886-8362
Principal Investigator: Dinesh Kapur, MD
Phone: 860-886-8362
Eastern Connecticut Hematology and Oncology Associates In 1985 Dr. Dennis Slater moved from Memorial Sloan-Kettering...
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Arlington, Texas 76012
Principal Investigator: Barry Firstenberg, MD
Phone: 817-543-4645
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Arlington, TX
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Belleville, New Jersey 07109
Principal Investigator: James Orsini, MD
Phone: 973-751-8880
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Boca Raton, Florida 33486
Principal Investigator: Edgaurdo Santos, MD
Phone: 561-955-4519
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1455 Harrison Avenue Northwest
Canton, Ohio 44708
Principal Investigator: Mitchell Haut, MD
Phone: 330-489-1274
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120 Lakeview Circle
Covington, Louisiana 70433
Principal Investigator: David Oubre, MD
Phone: 985-888-1523
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Fayetteville, Arkansas 72703
Principal Investigator: Eric Schaefer, MD
Phone: 479-878-5447
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601 West Terrell Avenue
Fort Worth, Texas 76104
Principal Investigator: Jordan Christopher, MD
Phone: 817-702-6776
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Fort Worth, Texas 76104
Principal Investigator: Ray D Page, DO, PhD
Phone: 817-341-5414
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Gettysburg, Pennsylvania 17325
Principal Investigator: Satish Shah, MD
Phone: 717-334-4033
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203 Cox Boulevard
Goldsboro, North Carolina 27534
Principal Investigator: James Atkins, MD
Phone: 919-587-9077
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600 Moye Boulevard
Greenville, North Carolina 27834
Principal Investigator: Paul Walker, MD
Phone: 252-744-1888
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104 Innovation Drive
Greenville, South Carolina 29607
Principal Investigator: Robert Siegel, MD
Phone: 864-603-6214
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Indianapolis, Indiana 46237
Principal Investigator: Nadeem Ikhlaque, MD
Phone: 317-528-7060
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405 East Jackson Avenue
Jonesboro, Arkansas 72401
Principal Investigator: Mazen Khalil, MD
Phone: 870-910-7723
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289 Southwest Stonegate Terrace
Lake City, Florida 32024
Principal Investigator: Waseemullah Khan, MD
Phone: 386-755-1655
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1999 Marcus Avenue
Lake Success, New York 11042
Principal Investigator: Morton Coleman, MD
Phone: 516-488-2918
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Massillon, Ohio 44646
Principal Investigator: Nagaprasad Nagajothi, MD
Phone: 330-489-1274
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600 Celebrate Life Parkway
Newnan, Georgia 30265
Principal Investigator: Patricia Thompson-Rich, MD
Phone: 770-400-6077
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Pleasanton, California 94588
Principal Investigator: Rishi Sawhney, MD
Phone: 925-734-8130
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Richmond, Virginia 23235
Principal Investigator: Brian Mitchell, MD
Phone: 804-288-7159
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Savannah, Georgia 31405
Principal Investigator: Mark Taylor, MD
Phone: 912-651-5771
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Tacoma, Washington 98405
Principal Investigator: Andrea Rose, MD
Phone: 253-428-8712
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Temple, Texas 76508
Principal Investigator: Alan Gowan, MD
Phone: 254-724-2111
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961 South Gloster Street
Tupelo, Mississippi 38801
Principal Investigator: Tan Jiahuai, MD
Phone: 662-377-4550
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801 University Boulevard East
Tuscaloosa, Alabama 35401
Principal Investigator: John Dubay, MD
Phone: 205-343-8331
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Valdosta, Georgia 31602
Principal Investigator: Eric Anderson, MD
Phone: 229-259-4698
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