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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
363
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.
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
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.
Clinical Research Advisors, LLC
Beverly Hills, California, United States
RECRUITINGClinical Research Advisors - Encino
Encino, California, United States
ACTIVE_NOT_RECRUITINGClinical Research Advisors - West Hollywood
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGClinical Research Advisors - Korea Town
Los Angeles, California, United States
OS defined as time from randomization to death
OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
Time frame: From randomization date through study completion, an average of 3 years
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SCL Health - Saint Joseph Hospital Cancer Center
Littleton, Colorado, United States
WITHDRAWNLutheran Medical Center - Cancer Centers of Colorado
Wheat Ridge, Colorado, United States
RECRUITINGEastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
RECRUITINGGeorgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
RECRUITINGComprehensive Hematology Oncology - Bradenton Clinic
Bradenton, Florida, United States
ACTIVE_NOT_RECRUITINGComprehensive Hematology Oncology - Brandon Clinic
Brandon, Florida, United States
ACTIVE_NOT_RECRUITING...and 195 more locations