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Monoclonal Antibodies

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

Phase 1 & 2

Waitlist Available

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 from date of registration until the date of death from any cause, assessed up to 2 years

Awards & highlights

FLT3 Trial Summary

This trial is testing a new immunotherapy treatment for lung cancer. It is comparing the safety and effectiveness of the new treatment to standard options.

Eligible Conditions

Non-Small Cell Lung Cancer
Lung Cancer

FLT3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration until the date of death from any cause, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration until the date of death from any cause, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration until the date of death from any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Dose-limiting Toxicity (DLT), Defined as Follows

Phase II: Progression-free Survival (PFS) Duration

Secondary outcome measures

Daily Step Count Using Descriptive Statistics

Overall Survival (OS) Duration

Quality of Life Using EORTC QLQ-LC13 (Quality of Life Questionnaire, Lung Cancer)

+2 more

FLT3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FLT3 ligand (CDX-301), anti-CD40 antibody (CDX-1140), and SBRTExperimental Treatment3 Interventions

Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points.

Group II: Standard careActive Control1 Intervention

Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBRT

2014

Completed Phase 2

~1060

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Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor

286 Previous Clinical Trials

11,856,976 Total Patients Enrolled

Celldex TherapeuticsIndustry Sponsor

60 Previous Clinical Trials

3,825 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this experiment?

"This trial is assessing Progression-free survival (PFS) duration over the 8 week study period as its primary outcome, and Overall Survival (OS), Quality of Life utilizing EORTC QLQ-C30 questionnaires, and Quality of Life using EORTC QLQ-LC13 surveys for secondary objectives. All metrics are evaluated on a scale from one to four with higher scores indicating greater levels of functioning."

Answered by AI

Is this trial still accepting new participants?

"The clinical trial is currently seeking participants, as indicated on the clinicaltrials.gov website which was last updated on July 18th 2022 and first posted in January 1st 2021."

Answered by AI

What is the aggregate count of participants in this experiment?

"Affirmative, details available on clinicaltrials.gov inform us that the trial is presently enrolling individuals into its research divisions. This study was initiated on January 1st 2021 and most recently revised on July 18th 2022; 46 patients are currently being sought across a single medical centre for this endeavour."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy

Nitin Ohri 2021. "FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04491084.