- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839265
FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (FLT3)
November 14, 2022 updated by: Nitin Ohri, Albert Einstein College of Medicine
Based on promising data from our laboratory demonstrating synergy between ablative local radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models, investigators are performing a phase II study combining FLT3L immunotherapy and SBRT for patients with advanced NSCLC that has progressed following standard systemic therapy.
All patients will receive daily subcutaneous injections of CDX-301 (75 µg/kg) for 5 days, beginning on the first day of SBRT.
SBRT will be delivered to a single pulmonary or extrapulmonary lesion.
The SBRT regimen will depend on the size and location of the target lesion.
The primary endpoint will be progression-free survival at 4 months, defined using immune-related response criteria (irRC).
A total of 29 patients will be enrolled.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary Objective
- To explore the efficacy of combining stereotactic body radiotherapy (SBRT) with FLT3 ligand immunotherapy for advanced non-small cell lung cancer (NSCLC).
Secondary Objectives
- To establish the feasibility and safety of combining SBRT with FLT3 ligand immunotherapy for advanced NSCLC.
- To quantify and evaluate potential surrogate outcomes for clinical efficacy of this treatment approach, including radiographic responses, immunologic responses, and circulating tumor cell levels.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- AJCC stage 3 or 4 histologically proven NSCLC not amenable to curative therapy
- Age >= 18 years
- Prior treatment with at least one standard chemotherapy regimen or targeted agent prior to enrollment
- 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
- History/physical examination within 30 days prior to registration
- ECOG performance status 0-2
- Signed, written informed consent
Exclusion Criteria:
- Less than 21 days between registration and the last receipt of chemotherapy, biotherapy, immunotherapy, radiotherapy (excluding palliative radiotherapy), or major surgery. Prior receipt of immunomodulatory therapy (eg: nivolumab) is permitted, as long as there has been a 21 day washout period following the most recent treatment.
- Untreated central nervous system metastases. Patients with a history of brain metastases must have had no CNS-directed therapy within the past 60 days and radiological assessment within 30 days of study entry demonstrating a lack of progressive CNS disease
- Ongoing or recent (within 21 days prior to study entry) use of high dose oral corticosteroids (.2 mg of dexamethasone daily or equivalent). Intranasal and/or inhaled corticosteroid use is permitted.
- Any unresolved CTCAE grade >2 toxicity from previous anti-cancer therapy. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study therapy (eg, hearing loss)may be enrolled after discussion with the principal investigators.
- History of allogeneic organ transplant or autoimmune disease
- Active malignancy, other than NSCLC, for which systemic therapy is indicated. History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for >= 5 years is permitted.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by the treating physicians
The following laboratory results, within 10 days of first study drug administration:
- Hemoglobin . 9.0 g/dL, Absolute neutrophil count . 1.5 x 109/L, Platelet count . 100 x 109/L
- Serum creatinine . 1.5 x ULN and creatinine clearance (by Cockcroft-Gault formula) < 60 mL/min
- Women of child bearing potential: positive pregnancy test (serum)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBRT + FLT3 Ligand Immunotherapy
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)
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See Arm 1 descriptions
See Arm 1 descriptions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival
Time Frame: 4 Months
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The primary endpoint is progression-free survival rate at four months (PFS4), defined as the rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (~4 months) after initiation of study therapy.
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4 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicities (DLTs)
Time Frame: 30 days
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Dose limiting toxicities (DLTs): For the purposes of this study, a DLT will be defined as any treatment-emergent grade 3-5 toxicity, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and occurring within 30 days after treatment with SBRT in combination with FLT3 ligand therapy.Asymptomatic laboratory abnormalities (eg: leukocytosis) that do not require intervention will not be counted as DLTs.
For subjects who receive more than one "cycle" of SBRT and FLT3 ligand, only adverse events that occur after the first cycle will be scored as potential DLTs.
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nitin Ohri, MD, Albert Einstein College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
October 5, 2022
Study Completion (Actual)
October 5, 2022
Study Registration Dates
First Submitted
July 15, 2016
First Submitted That Met QC Criteria
July 18, 2016
First Posted (Estimate)
July 20, 2016
Study Record Updates
Last Update Posted (Actual)
November 15, 2022
Last Update Submitted That Met QC Criteria
November 14, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Radiation-Protective Agents
- Flt3 ligand protein
Other Study ID Numbers
- 2015-5267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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