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Namzaric® for Lung Cancer (SPiRiT Trial)

Phase 3
Recruiting
Led By Katherine Peters, MD, PhD
Research Sponsored by Duke University
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 baseline, 15 weeks
Awards & highlights

SPiRiT Trial Summary

This trial is testing whether Namzaric can help improve cognitive function in cancer survivors who have received brain radiation as part of their standard of care therapy. It is also testing the feasibility of using a digital symptom tracking application to monitor health-related quality of life, cognition, and financial toxicity in these survivors.

Eligible Conditions
  • Lung Cancer
  • Brain Metastases
  • Brain Tumor

SPiRiT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation

SPiRiT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Namzaric® armExperimental Treatment1 Intervention
Arm 1 will take daily Namzaric® for 17 weeks, including 3 weeks of dose-escalation, 12 weeks at a stable dose, and a 2 week taper.
Group II: Placebo armPlacebo Group1 Intervention
Arm 2 will take daily placebo for 17 weeks, including 3 weeks of dose-escalation, 12 weeks at a stable dose, and a 2 week taper.

Find a Location

Who is running the clinical trial?

AllerganIndustry Sponsor
781 Previous Clinical Trials
276,519 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
58 Previous Clinical Trials
3,689 Total Patients Enrolled
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,436 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy
2021. "Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04567251.
~6 spots leftby Sep 2024
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