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

OSE Immunotherapeutics

Status and phase: Enrolling; Phase 3

Conditions: Patients With Non-Small Cell Lung Cancer

Treatments: Drug: OSE2101; Drug: Docetaxel; Device: NGS HLAA2 assay

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06472245

OSE2101C302

Details and patient eligibility

About

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).

Enrollment: 363 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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363 participants in 3 patient groups

Arm A: OSE2101

Experimental group

Description:

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.

Treatment:

Device: NGS HLAA2 assay

Drug: OSE2101

Arm B: Docetaxel

Active Comparator group

Description:

Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.

Treatment:

Device: NGS HLAA2 assay

Drug: Docetaxel

GenDx CDx Tedopi

Other group

Description:

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.

Treatment:

Device: NGS HLAA2 assay