Cancer Vaccine for Lung Cancer

(ARTEMIA Trial)

Recruiting at 145 trial locations

Overseen By Caroline Chevalier, MSc, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: OSE Immunotherapeutics

Disqualifiers: EGFR, ALK, ROS1, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the treatment OSE2101, Tedopi, for lung cancer?

Research on lung cancer vaccines shows that they can improve survival and reduce tumor growth in some patients, with a high safety profile. While specific data on OSE2101, Tedopi, is not provided, similar vaccines have shown promise in enhancing the body's immune response to fight cancer. ^{1 2 3 4 5}

Is the cancer vaccine OSE2101 (Tedopi) safe for humans?

The research articles provided do not contain specific safety data for the cancer vaccine OSE2101 (Tedopi) in humans. ^{1 3 6 7 8}

What makes the treatment OSE2101 (Tedopi) unique for lung cancer?

OSE2101 (Tedopi) is a cancer vaccine that works by enhancing the immune system's ability to recognize and attack tumor cells, which is different from traditional treatments like chemotherapy that directly target cancer cells. This approach aims to provide a more targeted and potentially less toxic option for patients with lung cancer. ^{3 5 7 9 10}

Eligibility Criteria

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 cancer stopped responding to immunotherapy.

I am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• OSE2101 (Cancer Vaccine)

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.

Participant Groups

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.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany 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. [2021]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Lung cancer vaccines. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Characteristics of clinical trials for non-small cell lung cancer therapeutic vaccines registered on ClinicalTrials.gov. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lung cancer vaccines. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. [2022]

7. United States 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. [2021]

8. China pubmed.ncbi.nlm.nih.gov

[The phase II clinical trial of Seratia Marcescens Anticancer Vaccine (S311) for malignant pleural effusions]. [2010]

9. Switzerland pubmed.ncbi.nlm.nih.gov

An EGFR L858R mutation identified in 1862 Chinese NSCLC patients can be a promising neoantigen vaccine therapeutic strategy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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