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Trial Title:
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
NCT ID:
NCT06472245
Condition:
Patients With Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Conditions: Keywords:
Immune Checkpoint Inhibitor
Cancer vaccine
Non-Small Cell Lung Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
OSE2101
Description:
OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2
phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3,
and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM
adjuvant.
Arm group label:
Arm A: OSE2101
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in
cells that is essential for mitotic and interphase cellular functions.
Arm group label:
Arm B: Docetaxel
Intervention type:
Device
Intervention name:
NGS HLAA2 assay
Description:
Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit
(library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of
NGS data files.
Arm group label:
Arm A: OSE2101
Arm group label:
Arm B: Docetaxel
Arm group label:
GenDx CDx Tedopi
Summary:
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with
squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with
OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification
factors will be histology (squamous versus non squamous) and ECOG Performance Status (0
versus 1).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. Patients with histologically or cytologically squamous or non-squamous documented
NSCLC, metastatic stage at study entry, not eligible for definite surgery or
radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted
therapy; other sensitizing mutations known to be immunosensitive are eligible in
case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF
mutations) after Sponsor's agreement
4. Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Georgetown Lombardi Comprehensive Cancer Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Facility:
Name:
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
Address:
City:
Merriam
Zip:
66204
Country:
United States
Facility:
Name:
NHO Revive Research Institute LLC
Address:
City:
Lincoln
Zip:
68506
Country:
United States
Facility:
Name:
Optum Medical Care - Carmel/Brewster Campus
Address:
City:
Brewster
Zip:
10509-2338
Country:
United States
Facility:
Name:
Optum Medical Care - Fishkill Westage Campus
Address:
City:
Fishkill
Zip:
12524
Country:
United States
Facility:
Name:
Optum Hematology Oncology - Lake Success
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Facility:
Name:
Optum Medical Care - Mount Kisco Campus 90
Address:
City:
Mount Kisco
Zip:
10549
Country:
United States
Facility:
Name:
Optum Medical Care - Poughkeepsie
Address:
City:
Poughkeepsie
Zip:
12601
Country:
United States
Facility:
Name:
Brooklyn Radiation Oncology
Address:
City:
Richmond Hill
Zip:
11418
Country:
United States
Facility:
Name:
Bon Secours Hematology and Oncology
Address:
City:
Greenville
Zip:
29607
Country:
United States
Start date:
June 30, 2024
Completion date:
December 15, 2028
Lead sponsor:
Agency:
OSE Immunotherapeutics
Agency class:
Industry
Collaborator:
Agency:
Exystat
Agency class:
Other
Collaborator:
Agency:
Genome Diagnostics (GenDx)
Agency class:
Other
Source:
OSE Immunotherapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06472245
