Lung Cancer > OSE2101

Cancer Vaccine for Lung Cancer

(ARTEMIA Trial)

Recruiting in Palo Alto (17 mi)

+145 other locations

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.

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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.

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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.

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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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Eastern Connecticut Hematology and Oncology Associates Norwich, CT

Georgetown Lombardi Comprehensive Cancer Center Washington, United States

Comprehensive Hematology Oncology - Bradenton Clinic Bradenton, FL

Comprehensive Hematology Oncology - Brandon Clinic Brandon, FL

More Trial Locations

Who Is Running the Clinical Trial?

OSE Immunotherapeutics Lead Sponsor

Exystat Collaborator

Genome Diagnostics (GenDx) Collaborator

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] To present an updated survival analysis of an open-label, parallel-group, phase IIB trial of BLP25 liposome vaccine (L-BLP25) in patients with stage IIIB or IV non-small-cell lung cancer (NSCLC).

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

Lung cancer vaccines. [2019] Cytotoxic chemotherapy is associated with modest survival advantage as initial treatment of advanced lung cancer. However, toxicity and minimal benefit to use second line treatment justifies exploration of alternative approaches. Recent understanding of mechanisms by which tumor antigen recognition can be enhanced has justified development of a recent flurry of vaccine trials in lung cancer. Preliminary results suggest a remarkably high safety profile and significant activity with respect to improvement in time to progression and survival in comparison to historical controls or lower dose treated cohorts, particularly in non small cell lung cancer. This review summarizes current results of vaccine trial development in non small cell and small cell lung cancer.

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

A review of vaccine clinical trials for non-small cell lung cancer. [2019] Recent evidence suggests that vaccines which enhance tumour antigen recognition may provide clinical benefit to subsets of non-small cell lung cancer patients. In this review, a variety of peptide-, gene- and cell-based clinical vaccine approaches targeting non-small cell lung cancer patients are reviewed. Results consistently demonstrate lack of toxicity. Examples of prolonged stable disease, tumour shrinkage response and survival benefit in comparison with historical and low-dose control groups have been demonstrated. Specific vaccines fulfilling justification for Phase III evaluation based on these results include LBLP25, TGF-beta2 antisense gene vaccine and GVAX.

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

Characteristics of clinical trials for non-small cell lung cancer therapeutic vaccines registered on ClinicalTrials.gov. [2022] Even after complete surgical treatment or chemotherapy, Non-Small Cell Lung Cancer (NSCLC) patients are also at substantial risk for recurrence and spread trend. Therapeutic cancer vaccination could increase the anti-tumor immune response and prevent tumor relapse. This study aimed to assess the characteristics of NSCLC therapeutic vaccines registered on ClinicalTrials.gov.

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

Lung cancer vaccines. [2021] To date, in lung cancer, early attempts to modulate the immune system via vaccine-based therapeutics have been unsuccessful. An improved understanding of tumor immunology has facilitated the production of more sophisticated lung cancer vaccines. It is anticipated that it will likely require multiple epitopes of a diverse set of genes restricted to multiple haplotypes to generate a truly effective vaccine that is able to overcome the various immunologic escape mechanisms that tumors employ. Other issues to overcome include optimal patient selection, which adjuvant agent to use, and how to adequately monitor for an immunologic response. This review discusses the most promising vaccination strategies for non-small cell lung cancer including the allogeneic tumor cell vaccine belagenpumatucel-L, which is a mixture of 4 allogeneic non-small cell lung cancer cell lines genetically modified to secrete an antisense oligonucleotide to transforming growth factor β2 and 3 other target protein-specific vaccines designed to induce responses against melanoma-associated antigen A3, mucin 1, and epidermal growth factor.

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

A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. [2022] We conducted a phase I/Ib, open-label, single-arm trial to assess the safety, tolerability and optimal scheduling regimen of OTSGC-A24 cancer vaccine in patients with advanced gastric cancer.

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] BLP25 liposome vaccine (L-BLP25) is an innovative therapeutic cancer vaccine designed to induce an immune response resulting in elimination of tumor cells expressing the MUC1 antigen, which is overexpressed in non-small-cell lung cancer (NSCLC). Manufacturing modifications have produced subtle changes to the lipid A acyl chain composition of L-BLP25. This open-label phase II study was conducted to evaluate the safety of the new formulation in patients with unresectable stage IIIA/IIIB NSCLC.

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

[The phase II clinical trial of Seratia Marcescens Anticancer Vaccine (S311) for malignant pleural effusions]. [2010] To evaluate the effect and adverse reactions of Seratia Marcescens Anticancer Vaccine ( S311) in the treatment of malignant pleural effusions.

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] This study aimed to develop a vaccine that targets mutation-derived neoantigen in Chinese non-small-cell lung cancer (NSCLC).

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

BLP-25 liposomal vaccine: a promising potential therapy in non-small-cell lung cancer. [2010] Despite marginal improvements in survival gained from multimodality treatment, long-term survival rates remain low for lung cancer, which remains the leading cause of cancer-related mortality in North America. BLP25 liposomal (L-BLP25) vaccine (Stimuvax) is a promising liposomal vaccine designed to generate an immune response against MUC1, a glycoprotein expressed on the cell surface of many normal epithelial tissues and over or aberrantly expressed on many carcinoma cells, including non-small-cell lung cancer (NSCLC). MUC1 is potentially a good target for immunotherapy, as evidenced by preclinical data and in Phase I and II clinical trials demonstrating the potential early activity of L-BLP25 with minimal toxicity in NSCLC. A Phase III randomized, placebo-controlled trial of L-BLP25 is currently being conducted in stage III NSCLC patients.