FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (FLT3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02839265|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer (NSCLC)||Drug: FLT3 Ligand Therapy (CDX-301) Radiation: Stereotactic Body Radiotherapy (SBRT)||Phase 2|
- To explore the efficacy of combining stereotactic body radiotherapy (SBRT) with FLT3 ligand immunotherapy for advanced non-small cell lung cancer (NSCLC).
- 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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
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)
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.
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|