Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Conditions

• Patients With Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• OSE2101 — DRUG
  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 — DRUG
  Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.
• NGS HLAA2 assay — DEVICE
  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.

Study Details

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).

Key Dates

Start date

Dec 3, 2024

Status verified

Mar 2026

Primary completion

Dec 15, 2027

Completion

Dec 15, 2028

Study Design

Enrollment

363 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: OSE2101
  Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year.
• Active Comparator: Arm B: Docetaxel
  Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
• Other: GenDx CDx Tedopi
  System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi.

Primary Outcome Measure

OS defined as time from randomization to death [ Time Frame: From randomization date through study completion, an average of 3 years ]

Central Contacts

• Caroline Chevalier, MSc, MPH
  +33 630 842 002
  [email protected]
• Bérangère Vasseur, MD
  +33 676 448 160
  [email protected]

Locations (79)

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