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CAR T-cell Therapy
AMG 160 for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Amgen
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 up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, AMG 160, to see if it is safe and how well it works. They will also determine the best dose of the drug to use.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)
+2 moreSecondary outcome measures
Duration of Response
Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Overall Survival
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion - Cohort 2 Squamous NSCLCExperimental Treatment1 Intervention
Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study.
Group II: Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLCExperimental Treatment1 Intervention
Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study.
Group III: Part 1: Dose ExplorationExperimental Treatment1 Intervention
The dose exploration part of the study will estimate the MTD and/or the RP2D.
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Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,103 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,576 Total Patients Enrolled
Frequently Asked Questions
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