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Immunotherapy

Stereotactic Body Radiotherapy (SBRT) for Non-Small Cell Lung Cancer (FLT3 Trial)

Phase 2
Waitlist Available
Led By Nitin Ohri, MD
Research Sponsored by Albert Einstein College of Medicine
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 4 months
Awards & highlights

FLT3 Trial Summary

This trial is testing whether a combination of two cancer treatments, FLT3L immunotherapy and SBRT, can help people with advanced NSCLC that has progressed following standard systemic therapy. The primary endpoint will be progression-free survival at 4 months.

Eligible Conditions
  • Non-Small Cell Lung Cancer

FLT3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival
Secondary outcome measures
Dose limiting toxicities (DLTs)

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Pain, flank
8%
Other, Creatinine decreased
8%
Lymphedema
8%
Hearing impaired
8%
Bleed (hemorrhage), gastrointestinal
8%
Edema, localized
8%
Thromboembolic event
8%
Allergic reaction
8%
Chills
8%
Fever
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Muscle weakness lower limb
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

FLT3 Trial Design

1Treatment groups
Experimental Treatment
Group I: SBRT + FLT3 Ligand ImmunotherapyExperimental Treatment2 Interventions
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy. FLT3 Ligand Therapy (CDX-301) Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT. Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression). Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
FLT3 Ligand Therapy (CDX-301)
2016
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,079 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
61 Previous Clinical Trials
3,921 Total Patients Enrolled
Nitin Ohri, MDPrincipal InvestigatorAlbert Einstein College of Medicine
6 Previous Clinical Trials
442 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
FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer
Nitin Ohri 2016. "FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02839265.
~3 spots leftby Apr 2025
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