A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:September 22, 2017
End Date:September 18, 2020
Contact:Reference Study ID Number: BO29554 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate
the safety and efficacy of targeted therapies or immunotherapy as single agents or in
combination in participants with unresectable, advanced or metastatic NSCLC determined to
harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as
identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA)
assays.


Inclusion Criteria:

- No prior systemic treatment for unresectable stage IIIB or IV NSCLC

- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not
amenable to treatment with combined modality chemoradiation (advanced) or Stage IV
(metastatic) NSCLC

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

- Measurable disease

- Adequate recovery from most recent systemic or local treatment for cancer

- Adequate organ function

- Life expectancy greater than or equal to (>/=) 12 weeks

- For female participants of childbearing potential and male participants, willingness
to use acceptable methods of contraception

Exclusion Criteria:

- Inability to swallow oral medication

- Women who are pregnant or lactating

- Symptomatic, untreated CNS metastases

- History of malignancy other than NSLCL within 5 years prior to screening with the
exception of malignancies with negligible risk of metastasis or death

- Significant cardiovascular disease, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction, or cerebrovascular accident within 3
months prior to randomization, unstable arrhythmias, or unstable angina

- Known human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome
(AIDS)-related illness

- Either a concurrent condition or history of a prior condition that places the patient
at unacceptable risk if he/she were treated with the study drug or confounds the
ability to interpret data from the study

- Inability to comply with other requirements of the protocol
We found this trial at
25
sites
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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3320 Old Jefferson Road
Athens, Georgia 30607
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Athens, GA
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Austin, Texas 78745
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Austin, TX
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Bethlehem, Pennsylvania
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Bethlehem, PA
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353 Avenida Callao
Buenos Aires, C1022
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Buenos Aires,
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Denver, Colorado 80218
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Denver, CO
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fairfax, VA
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Fort Myers, FL
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Houston, Texas 77203
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Houston, TX
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lexington, KY
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300 20th Avenue North
Nashville, Tennessee 37203
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195 Little Albany Street
New Brunswick, New Jersey 08901
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New York, NY
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Norwich, CT
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Peoria, Illinois 61656
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1130 Northwest 22nd Avenue
Portland, Oregon 97210
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Portland, OR
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Sacramento, CA
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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