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Anti-tumor antibiotic
Nivolumab for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Led By David Gerber, MD
Research Sponsored by RTOG Foundation, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration to study termination. maximum follow-up was 14.9 months.
Awards & highlights
Study Summary
This trial tests if nivolumab can help treat Stage III lung cancer when used with radiation & chemotherapy.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to study termination. maximum follow-up was 14.9 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to study termination. maximum follow-up was 14.9 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Secondary outcome measures
Number of Participants With Grade 3+ Adverse Events
Overall Survival by PD-L1 Status
Percentage of Participants With Deterioration in Functional Assessment of Cancer Therapy - Trial Outcome Index for Lung Cancer (FACT-TOI) at 15 Months
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NivolumabExperimental Treatment4 Interventions
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
Group II: PlaceboPlacebo Group4 Interventions
60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy (RT)
2008
Completed Phase 2
~230
Cisplatin
FDA approved
Etoposide
FDA approved
Nivolumab
FDA approved
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,646 Previous Clinical Trials
4,131,138 Total Patients Enrolled
RTOG Foundation, Inc.Lead Sponsor
6 Previous Clinical Trials
1,492 Total Patients Enrolled
David Gerber, MDPrincipal InvestigatorRTOG Foundation
5 Previous Clinical Trials
187 Total Patients Enrolled
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