Cancer Vaccine for Lung Cancer

(ARTEMIA Trial)

Recruiting at 234 trial locations

Overseen By Caroline Chevalier, MSc, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: OSE Immunotherapeutics

Disqualifiers: EGFR, ALK, ROS1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

363 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer vaccine, OSE2101 (also known as Tedopi), for individuals with advanced lung cancer that no longer responds to certain immune therapies. The goal is to determine if this vaccine can combat lung cancer more effectively than the standard treatment, docetaxel. Participants will receive either the vaccine or the standard drug, based on their assigned group. The trial seeks individuals whose lung cancer has spread, who have a specific blood marker called HLA-A2, and whose cancer has resisted previous immune treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that OSE2101, the cancer vaccine under study, is generally safe for people. Studies have found it causes fewer serious side effects than traditional chemotherapy. In earlier research, patients experienced a better quality of life and fewer negative effects with OSE2101. Importantly, no unexpected safety issues have been reported, making it a promising option for those with advanced lung cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about OSE2101 for lung cancer because it functions as a cancer vaccine, training the immune system to recognize and attack cancer cells. Unlike standard chemotherapy treatments like Docetaxel, which directly target and kill rapidly dividing cells, OSE2101 uses a combination of peptides administered through subcutaneous injection to stimulate a targeted immune response. This approach could potentially lead to fewer side effects and offer a more personalized treatment option by harnessing the body's own defenses against cancer.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research shows that OSE2101, a cancer vaccine, may help treat certain lung cancers. In this trial, participants in Arm A will receive OSE2101. Previous studies have shown that patients who received OSE2101 lived longer than those who had standard chemotherapy, with the vaccine reducing the risk of death by 41%. It also caused fewer severe side effects, with only 11.4% of patients experiencing major issues compared to 35.1% with standard treatment. Additionally, patients using OSE2101 reported a better quality of life. These results suggest that OSE2101 could be a good treatment option for lung cancer patients who no longer respond to other immune therapies. Participants in Arm B will receive Docetaxel, the active comparator in this trial. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My cancer stopped responding to immunotherapy.

My lung cancer is advanced, not operable, lacks certain gene changes, but may have others if no targeted treatments are available.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OSE2101 or Docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection every three weeks for six cycles, then every eight weeks for the remainder of year one, and every twelve weeks until the end of the second year. Docetaxel is administered as an intravenous infusion every three weeks.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• OSE2101

Trial Overview 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.

How Is the Trial Designed?

Group I: GenDx CDx Tedopi Experimental Treatment 1 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: OSE2101 Experimental Treatment 2 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: Docetaxel Active Control 2 Interventions

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

OSE2101 is already approved in European Union, United States for the following indications:

Approved in European Union as Tedopi for:

• Non-Small Cell Lung Cancer (NSCLC) with secondary resistance to immune checkpoint inhibitors in HLA-A2 positive patients

Approved in United States as Tedopi for:

• Orphan drug designation for Non-Small Cell Lung Cancer (NSCLC)

Who Is Running the Clinical Trial?

OSE Immunotherapeutics

Lead Sponsor

Trials

11

Recruited

1,300+

Exystat

Collaborator

Trials

6

Recruited

2,700+

Genome Diagnostics (GenDx)

Collaborator

Trials

1

Recruited

360+

Published Research Related to This Trial

The BLP25 liposomal vaccine (L-BLP25) is designed to stimulate an immune response against MUC1, a protein commonly found on cancer cells, particularly in non-small-cell lung cancer (NSCLC), which is a major cause of cancer deaths in North America.

Early clinical trials (Phase I and II) have shown that L-BLP25 may have promising activity with minimal toxicity, and a Phase III trial is currently underway to further evaluate its efficacy in patients with stage III NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BLP-25 liposomal vaccine: a promising potential therapy in non-small-cell lung cancer. Powell, E., Chow, LQ.[2010]

The BLP25 liposome vaccine (L-BLP25) was administered to 22 patients with unresectable stage IIIA/IIIB non-small-cell lung cancer, showing a safety profile similar to the original formulation, with mostly mild adverse events and only one grade 3 event (pneumonia).

After a median follow-up of 26.7 months, the vaccine demonstrated promising efficacy with a 1-year survival rate of 82% and a 2-year survival rate of 64%, indicating its potential as a therapeutic option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer. Butts, C., Murray, RN., Smith, CJ., et al.[2021]

The OTSGC-A24 cancer vaccine was well tolerated in a phase I/Ib trial with 24 patients suffering from advanced gastric cancer, showing no dose-limiting toxicities and manageable side effects like decreased appetite and injection site reactions.

Significant immune responses were observed, with 90% of patients showing positive cytotoxic T lymphocyte (CTL) responses at 12 weeks, leading to a recommended dosing schedule of 1 mg every 2 weeks for further studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. Sundar, R., Rha, SY., Yamaue, H., et al.[2022]

Recent advancements in understanding tumor immunology have led to the development of more sophisticated lung cancer vaccines, which may require targeting multiple tumor-specific epitopes to be effective against immune evasion.

One promising candidate is the allogeneic tumor cell vaccine belagenpumatucel-L, which uses genetically modified lung cancer cell lines to enhance immune response by secreting specific antisense oligonucleotides and targeting proteins associated with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer vaccines. Kelly, RJ., Giaccone, G.[2021]

Vaccines designed to enhance tumor antigen recognition in non-small cell lung cancer patients show promising results, including prolonged stable disease and tumor shrinkage, with no reported toxicity.

Specific vaccines such as LBLP25, TGF-beta2 antisense gene vaccine, and GVAX have demonstrated potential benefits that warrant further Phase III clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of vaccine clinical trials for non-small cell lung cancer. Nemunaitis, J., Nemunaitis, J.[2019]

The study identified the EGFR L858R mutation as the most prevalent variant in Chinese non-small-cell lung cancer (NSCLC) patients, suggesting it as a key target for neoantigen-based vaccines.

Neoantigen vaccines targeting EGFR L858R, particularly in patients with the HLA A*33:03 allele, may provide an effective treatment option for patients who have not responded to standard therapies like targeted therapy or immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An EGFR L858R mutation identified in 1862 Chinese NSCLC patients can be a promising neoantigen vaccine therapeutic strategy. Lin, J., Liu, J., Hao, SG., et al.[2022]

Patients with stage IIIB or IV non-small-cell lung cancer (NSCLC) who received the BLP25 liposome vaccine (L-BLP25) along with best supportive care (BSC) had a median survival time of 17.2 months, which is 4.2 months longer than those receiving BSC alone (13.0 months).

In a specific subgroup of patients with stage IIIB loco-regional disease, the median survival time increased significantly to 30.6 months with L-BLP25 plus BSC compared to 13.3 months with BSC alone, highlighting the potential efficacy of L-BLP25 in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial. Butts, C., Maksymiuk, A., Goss, G., et al.[2021]

In a study involving 241 patients with malignant pleural effusions, the Seratia Marcescens Anticancer Vaccine (S311) demonstrated a high overall response rate of 92.1%, indicating its efficacy in treatment.

The main adverse reactions included fever and pleuritic pain, with some patients experiencing chills, dyspnea, nausea, vomiting, and occasional liver dysfunction, suggesting that while S311 is effective, it can also cause significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The phase II clinical trial of Seratia Marcescens Anticancer Vaccine (S311) for malignant pleural effusions]. Zhu, Y., Shi, H., Qian, H., et al.[2010]

Recent vaccine trials for lung cancer, particularly non-small cell lung cancer, show a high safety profile and significant activity in improving survival and time to progression compared to historical controls.

Cytotoxic chemotherapy offers only modest survival benefits and is associated with toxicity, highlighting the need for alternative treatments like vaccines that may provide better outcomes with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer vaccines. Eager, R., Harle, L., Nemunaitis, JJ.[2019]

A total of 117 clinical trials for therapeutic vaccines targeting Non-Small Cell Lung Cancer (NSCLC) were analyzed, revealing a trend of increasing research activity, with 45.30% of trials completed and a significant portion funded by industry.

Most trials lacked randomized control and masking, with over half recruiting fewer than 50 participants, indicating potential limitations in the robustness of the findings; however, protein/peptide vaccines were the most commonly studied type, particularly for patients in advanced stages (III-IV) of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of clinical trials for non-small cell lung cancer therapeutic vaccines registered on ClinicalTrials.gov. Gu, W., Xu, Y., Chen, X., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS8651

Phase 3 trial of the therapeutic cancer vaccine OSE2101 ... In the randomized ATALANTE-1 study, OSE2101 significantly improved OS with a better safety profile and quality of life (QoL) compared to third- ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)00790-1/fulltext

Randomized open-label controlled study of cancer vaccine ... Grade ≥3 adverse effects occurred in 11.4% of patients with OSE2101 and 35.1% in SoC (P = 0.002). Conclusions. In HLA-A2-positive patients with ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37704166/

Randomized open-label controlled study of cancer vaccine ... ATALANTE-1 was a two-step open-label study to evaluate the efficacy and safety of OSE2101 compared to standard-of-care (SoC) chemotherapy (CT).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02654587

NCT02654587 | OSE2101 Versus Chemotherapy in HLA- ... The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT400096

Prognostic factors of overall survival (OS) in non-small cell ... Background: OSE2101 (Tedopi) is an anticancer vaccine that has shown an improvement in overall survival (OS) compared with Chemotherapy (CT) (HR 0.59; p = 0.017) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06472245

Study Details | NCT06472245 | Trial of Therapeutic Cancer ... 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 ...

7. ose-immuno.com ose-immuno.com/wp-content/uploads/2025/06/EN_250602_Post-ASCO_vf.pdf

EN_250602_Post-ASCO_vf.pdf In lung cancer, patient recruitment is progressing per plan in the Artemia Phase 3 registration study, a key milestone bringing us one step ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7506388/

1260MO Activity of OSE-2101 in HLA-A2+ non-small cell lung ... The Step-1 primary endpoint was positively achieved with a 1y-OS rate of 46% and a good safety profile. Step-1 results shown a favorable benefit/risk of Tedopi® ...