Patients With Non-Small Cell Lung Cancer
Conditions
Keywords
Immune Checkpoint Inhibitor, Cancer vaccine, Non-Small Cell Lung Cancer
Brief 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).
Interventions
DRUGOSE2101
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.
DRUGDocetaxel
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
DEVICENGS HLAA2 assay
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.
Sponsors
OSE Immunotherapeutics
Exystat
Genome Diagnostics (GenDx)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; 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' agreement. 4. Patients with secondary resistance to ICI; Other inclusion and
Exclusion criteria
will apply per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS defined as time from randomization to death | From randomization date through study completion, an average of 3 years | OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date |
Countries
Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, United Kingdom, United States
Contacts
CONTACTCaroline Chevalier, MSc, MPH
CONTACTBérangère Vasseur, MD
Outcome results
None listed