FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (FLT3)
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ClinicalTrials.gov Identifier: NCT02839265 |
Recruitment Status :
Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : November 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer (NSCLC) | Drug: FLT3 Ligand Therapy (CDX-301) Radiation: Stereotactic Body Radiotherapy (SBRT) | Phase 2 |
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 (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer |
Actual Study Start Date : | July 2016 |
Estimated Primary Completion Date : | October 5, 2022 |
Estimated Study Completion Date : | October 5, 2022 |

Arm | Intervention/treatment |
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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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Drug: FLT3 Ligand Therapy (CDX-301)
See Arm 1 descriptions Radiation: Stereotactic Body Radiotherapy (SBRT) See Arm 1 descriptions
Other Name: Stereotactic Ablative Radiotherapy (SABR) |
- Progression-Free Survival [ Time Frame: 4 Months ]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.
- Dose limiting toxicities (DLTs) [ Time Frame: 30 days ]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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839265
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Nitin Ohri, MD | Albert Einstein College of Medicine |
Responsible Party: | Nitin Ohri, Associate Professor, Albert Einstein College of Medicine |
ClinicalTrials.gov Identifier: | NCT02839265 |
Other Study ID Numbers: |
2015-5267 |
First Posted: | July 20, 2016 Key Record Dates |
Last Update Posted: | November 10, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Flt3 ligand protein Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Radiation-Protective Agents Protective Agents |