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Immunotherapy

FLT3 Ligand + Radiotherapy for 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

Age >= 18 years

Radiological assessment within 21 days prior to study entry demonstrating measurable disease that includes at least one pulmonary lesion ≥ 1 cm in greatest dimension that would be amenable to SBRT and at least one measurable lesion that would be outside of the SBRT treatment fields

Must not have

History of allogeneic organ transplant or autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of treatment to date of death, up to 5 years

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) that can't be cured and who have already tried at least one standard treatment. They should have a tumor suitable for targeted radiotherapy, plus other measurable disease outside the target area.

What is being tested?

The study tests combining FLT3 Ligand immunotherapy (CDX-301) with Stereotactic Body Radiotherapy (SBRT). Patients will get daily shots of CDX-301 alongside SBRT to a single lesion, aiming to improve progression-free survival at four months.

What are the potential side effects?

Possible side effects include reactions at the injection site from CDX-301, fatigue, skin reactions from radiation, and potential damage to nearby organs or tissues due to SBRT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a lung tumor larger than 1 cm that can be treated with SBRT and another measurable tumor outside of this treatment area.

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My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.

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I have received at least one standard chemotherapy or targeted therapy before.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant or have an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of treatment to date of death, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of treatment to date of death, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of treatment to date of death, up to 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

Progression-Free Survival

Secondary study objectives

Dose Limiting Toxicities (DLTs)

Overall Survival (OS)

Radiographic Response Rate Based on PET Response Criteria in Solid Tumors (PERCIST)

+1 more

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)

Chills

Fever

Allergic reaction

Bleed (hemorrhage), gastrointestinal

Hearing impaired

Edema, localized

Other, Creatinine decreased

Pain, flank

Muscle weakness lower limb

Drowsiness, unusual (somnolence)

Tiredness (fatigue)

Lymphedema

Thromboembolic event

Abdominal distention

Abnormal sensation in the mouth (oral dysesthesia)

Dry mouth

Gastroesophageal reflux disease

Pain, stomach

Pain, chest, non-cardiac

Lymphocyte count increased

Other, Neutrophil count increase

Other, Protein total decrease

Thrombocytopenia

Weight gain

Hypercalcemia

Hypernatremia

Dizziness

Nerve tingling (paresthesia)

Slow or slurred speech (dysarthria)

Tremor

Rash

Gastroparesis

Flu-like symptoms

Alkaline phosphatase decreased

Blood bilirubin increased

Dehydration

Nerve damage or injury (neuropathy), peripheral sensory

Confusion

Other, axilla boil

Other, hemoglobin decreased

Infusion-related reaction

Arthritis

Generalized muscle weakness

Memory impairment

Movements involuntary

Chronic kidney disease

Cataract

Other, excess in the stool (steatorrhea)

Other, stool discolored, clay color

Gamma-glutamyl transferase (GGT) increased

Hypoglycemia

Urinary incontinence

Urinary urgency

Urine discoloration

Excessive sweating (hyperhidrosis)

100%

80%

60%

40%

20%

Study treatment Arm

Modified FOLFIRINOX

Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

Awards & Highlights

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: 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)

2017

Completed Phase 3

~550

0 / 6Eligibility criteria met