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Cancer Vaccine

Arm A: OSE2101 for Lung Cancer (ARTEMIA Trial)

Phase 3
Waitlist Available
Research Sponsored by OSE Immunotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization date through study completion, an average of 3 years
Awards & highlights

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).

Who is the study for?
This trial is for HLA-A2 positive patients with advanced non-small cell lung cancer who have stopped responding to immune checkpoint inhibitors. Participants should be able to perform daily activities with minimal assistance (ECOG Performance Status of 0 or 1). Specific details about inclusion and exclusion criteria are not provided.
What is being tested?
The study compares OSE2101, a therapeutic cancer vaccine, against docetaxel, a standard chemotherapy drug. Patients will either receive the vaccine alone or the chemo alone in a ratio of two-to-one by chance. The trial considers their type of lung cancer and physical fitness level.
What are the potential side effects?
Possible side effects for OSE2101 may include immune-related reactions due to its nature as a vaccine. Docetaxel can cause hair loss, nausea, fatigue, low blood cell counts increasing infection risk, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization date through study completion, an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OS defined as time from randomization to death

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: GenDx CDx TedopiExperimental Treatment1 Intervention
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.
Group II: Arm A: OSE2101Experimental Treatment2 Interventions
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.
Group III: Arm B: DocetaxelActive Control2 Interventions
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.

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Who is running the clinical trial?

ExystatOTHER
5 Previous Clinical Trials
2,392 Total Patients Enrolled
OSE ImmunotherapeuticsLead Sponsor
10 Previous Clinical Trials
980 Total Patients Enrolled
Genome Diagnostics (GenDx)UNKNOWN
~242 spots leftby Dec 2027
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