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Cancer Vaccine

Cancer Vaccine for Lung Cancer (ARTEMIA Trial)

Phase 3

Recruiting

Research Sponsored by OSE Immunotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with secondary resistance to ICI

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

Pivotal Trial

No Placebo-Only Group

Summary

This trial will enroll patients with a specific type of lung cancer that has not responded to immunotherapy. Patients will be divided into two groups: one group will receive OSE2101 treatment, while the

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

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My cancer stopped responding to immunotherapy.

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My blood test shows I have the HLA-A2 type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization date through study completion, an average of 3 years

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met