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Alkylating agents

radiation therapy for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Kristin Higgins, MD
Research Sponsored by Emory 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 at 5 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing if SBRT can be safely given to patients with advanced lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute toxicities associated with this regimen using CTCAE v.4
Late toxicities associated with this regimen using CTCAE v.4
Secondary study objectives
Distant metastasis
Local control
Overall survival
+1 more

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597
44%
Acute RT Toxicity: Bowel: NOS
29%
Hormone Toxicity: Hot flashes : NOS
26%
Late RT Toxicity: Bowel: NOS
24%
Hormone Toxicity: Impotence : NOS
18%
Late RT Toxicity: Bladder: NOS
17%
Hormone Toxicity: Hematologic : NOS
15%
Acute RT Toxicity: Bladder: NOS
13%
Acute RT Toxicity: Hematologic: NOS
13%
Late RT Toxicity: Hematologic: NOS
13%
Acute RT Toxicity: Other: NOS
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)Experimental Treatment4 Interventions
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiation therapy
1994
Completed Phase 3
~13390
stereotactic body radiation therapy
2019
Completed Phase 2
~480
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,725 Total Patients Enrolled
Washington University Siteman Cancer CenterOTHER
2 Previous Clinical Trials
69 Total Patients Enrolled
Kristin Higgins, MDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
95 Total Patients Enrolled
~1 spots leftby Nov 2025
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