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) |
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.
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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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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