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Trial record 1 of 4 for:    ose 2101
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Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC (ATALANTE 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
OSE Immunotherapeutics
ClinicalTrials.gov Identifier:
NCT02654587
First received: January 8, 2016
Last updated: August 11, 2017
Last verified: April 2017
  Purpose
The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: OSE2101 Drug: Docetaxel Drug: Pemetrexed Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Locally Advanced (IIIB) Unsuitable for Radiotherapy or Metastatic (IV) Non-Small-Cell Lung Cancer. (OSE2101C301)

Resource links provided by NLM:


Further study details as provided by OSE Immunotherapeutics:

Primary Outcome Measures:
  • Overall Survival time (OS) [ Time Frame: Approximatively 24 months ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Approximatively 24 months ]
  • QLQ-C30 global score [ Time Frame: Approximatively 24 months ]
  • QLQ-LC13 global score [ Time Frame: Approximatively 24 months ]
  • Objective Response Rate (ORR) [ Time Frame: Approximatively 24 months ]
  • Patient Reported Outcomes (PRO) [ Time Frame: Approximatively 24 months ]

Other Outcome Measures:
  • Disease Control Rate (DCR) [ Time Frame: Approximatively 24 months ]
  • Duration of Response (DR) [ Time Frame: Approximatively 24 months ]
  • Time to deterioration (TTD) [ Time Frame: Approximatively 24 months ]
  • Time to next lung cancer therapy [ Time Frame: Approximatively 24 months ]
  • Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities [ Time Frame: Approximatively 48 months ]
    Safety and tolerability of OSE2101 compared to pemetrexed or docetaxel


Enrollment: 131
Study Start Date: February 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OSE2101
OSE2101 will be administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every two months for the remainder of year one and finally every three months until unequivocal Recist 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. OSE2101 dose will be 5 mg of peptide (0.5 mg for each peptide).
Drug: OSE2101
Other Names:
  • Tedopi
  • EP-2101
  • EP2101
  • IDM-2101
Active Comparator: Docetaxel or Pemetrexed

Patients receiving docetaxel: Docetaxel 75 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of a 21-day cycle.

Patients receiving pemetrexed: Pemetrexed, 500 mg/m2, will be administered by intravenous infusion over 10 minutes on Day 1 of a 21-day cycle.

Drug: Docetaxel
Other Name: Taxotere
Drug: Pemetrexed
Other Name: Alimta

Detailed Description:

The aim of this study is to demonstrate that OSE2101 (Arm A) is superior to standard chemotherapy, pemetrexed or docetaxel (Arm B), in prolonging overall survival (OS) in HLA-A2 positive patients with locally advanced (IIIB) or metastatic (IV) NSCLC as 2nd or 3rd line therapy after failure of prior platinum-based chemotherapy or after failure of platinum- and checkpoint-inhibitor regimens.

Treatment cycles will be repeated until unequivocal Recist 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
  2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  3. Female or male, 18 years of age or older.
  4. Histologically or cytologically proven diagnosis of NSCLC that is locally advanced (stage IIIB) unsuitable for radiotherapy or metastatic (stage IV) according to the 7th edition of tumor, node, metastasis (TNM) in Lung Cancer published by the International Union Against Cancer and the American Joint Committee on Cancer.
  5. Subjects with disease recurrence or progression

    1. Patients must have had progressive disease after only one prior chemotherapy regimen: i) It includes patients who have received one prior platinum-based chemotherapy in the adjuvant setting following surgical resection for early disease and whose disease has recurred within 12 months of completion of prior chemotherapy, ii) It includes patients who received one prior platinum-based chemotherapy in combination with radiation therapy for Stage III locoregional disease and whose disease has recurred within 12 months of completion of prior chemotherapy, iii) It includes patients who received 2 prior platinum-based chemotherapy regimens, if the first regimen was given as adjuvant therapy or was given in combination with radiation therapy for locally advanced disease
    2. or Patients must have had progressive disease after therapy with an immune checkpoint inhibitor and platinum-based chemotherapy (either 1st line chemotherapy followed by 2nd line checkpoint inhibitor, or 1st line checkpoint inhibitor followed by 2nd line chemotherapy, or 1st line combination of checkpoint inhibitor and chemotherapy)
  6. Subjects with measurable or non-measurable lesions.
  7. Subjects must express HLA-A2 phenotype as assessed serologically.
  8. Subjects must be considered suitable for chemotherapy with either single-agent pemetrexed or docetaxel.
  9. Subjects with brain metastases are eligible if treated (whole brain radiotherapy, stereotaxic radiotherapy, surgery) and have no symptoms (except for signs and symptoms related to central nervous system therapy) for at least 2 weeks before initiation of allocated treatment and are not taking any forbidden medications.
  10. Any prior chemotherapy, immunotherapy, radiation therapy or surgeries must have been completed at least 3 weeks prior to initiation of study medication.
  11. Any toxicity from prior therapy must have recovered to ≤ Grade 1 (except alopecia).
  12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  13. Adequate organ function as defined by all the following criteria:

    • Albuminemia > 25g/L
    • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN) with alkaline phosphatase ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to liver metastases
    • Total serum bilirubin ≤ 1.5 x ULN
    • Absolute neutrophil count (ANC) ≥ 1500/L
    • Platelets ≥ 100000/L
    • Hemoglobin ≥ 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization)
    • Creatinine clearance (based on modified Cockcroft-Gault formula) ≥ 45 ml/min.

Exclusion Criteria:

  1. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas). Large-cell carcinoma.
  2. NSCLC that is predominantly squamous cell carcinoma, and patient had docetaxel as part of his prior chemotherapy.
  3. Current or previous treatment with investigational therapy in another therapeutic clinical trial interrupted less than 4 weeks before study treatment initiation.
  4. Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK) rearrangement.
  5. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy).
  6. Spinal cord compression (unless treated with the patient attaining good pain control and stable or recovered neurologic function), carcinomatous meningitis, or leptomeningeal disease
  7. Patients with squamous cell histology or non-squamous cell histology previously treated by pemetrexed and with a contraindication for docetaxel with grade ≥ 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80) as they could be randomly assigned to Arm B.
  8. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
  9. Treatment with corticosteroids in the last 3-week period before inclusion, except for topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption (e.g. with a dose ≤ 500 microgram beclomethasone equivalent for inhaled steroids), or adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent which are permitted.
  10. A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection (and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies).
  11. Patients with auto-immune disease, with the exception of type I diabetes or treated hypothyroidism.
  12. Patients with interstitial lung disease.
  13. Patients with active B or C hepatitis.
  14. Other malignancy: patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or localized cervical cancer, or localized and presumed cured prostate cancer).
  15. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
  16. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment.
  17. Male patients sexually active with a woman of childbearing potential must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator.
  18. Breastfeeding women.
  19. Women with a positive pregnancy test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02654587

  Show 88 Study Locations
Sponsors and Collaborators
OSE Immunotherapeutics
Orion Corporation, Orion Pharma
  More Information

Publications:
Responsible Party: OSE Immunotherapeutics
ClinicalTrials.gov Identifier: NCT02654587     History of Changes
Other Study ID Numbers: OSE2101C301
2015-003183-36 ( EudraCT Number )
Study First Received: January 8, 2016
Last Updated: August 11, 2017

Keywords provided by OSE Immunotherapeutics:
Non-Small-Cell Lung Cancer
NSCLC
Immunotherapy
Cancer vaccine
Metastasis

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017