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Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor (ATALANTE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654587
Recruitment Status : Unknown
Verified March 2021 by OSE Immunotherapeutics.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
OSE Immunotherapeutics

Study Description
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Brief Summary:
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 after failure of immune checkpoint-inhibitor regimens.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: OSE2101 Drug: Docetaxel Drug: Pemetrexed Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Step 1 primary objective: Overall Survival rate (approx. 100 patients) / Step 2 primary objective: Overall Survival (approx. 363 patients in total, number to be reassessed based on the step 1 results)
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 Advanced Non-Small-Cell Lung Cancer With Progressive Disease After Last Treatment With Immune Checkpoint Inhibitors (ICI). (OSE2101C301)
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OSE2101
OSE2101 will be administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every eight weeks for the remainder of year one and finally every twelve weeks beyond year one until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. Should pseudo progression or delayed response to treatment suspected in arm A, investigator may continue treatment beyond the time of RECIST-defined progression, if the patient is perceived to be experiencing clinical benefit. 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.

Docetaxel and pemetrexed will be continued until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.

 Drug: Docetaxel
Other Name: Taxotere

Drug: Pemetrexed
Other Name: Alimta


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival time (OS) [ Time Frame: Approx. 24 months ]
    • In Step 1: OS rate at 12 months in experimental Arm A (OSE2101) in 84 evaluable patients exposed to OSE2101
    • In Step 2: comparison of OS between experimental Arm A (OSE2101) and control Arm B (docetaxel or pemetrexed) when 278 events observed


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) at 6 months [ Time Frame: 6 months ]
  2. QLQ-C30 (EORTC QLQ questionnaire): "Global health status/QoL" score based on questions 29 [ Time Frame: Approx. 24 months ]
  3. QLQ-LC13 (lung cancer module from EORTC QLQ questionnaire): time to 1st ≥ 10-point deterioration in (question 40), dyspnea (questions 33, 34, 35) or cough (question 31) [ Time Frame: Approx. 24 months ]
  4. Progression Free Survival (PFS) [ Time Frame: Approx. 24 months ]
  5. Objective Response Rate (ORR) (in Step 1 only) [ Time Frame: Approx. 24 months ]
  6. DCR at 12 months (in Step 1 only) [ Time Frame: Approx. 24 months ]
  7. Duration of Response (DR) (in Step 1 only) [ Time Frame: Approx. 24 months ]
  8. Safety and tolerability profile compared to the control group [ Time Frame: Approx. 24 months ]

Other Outcome Measures:
  1. Objective Response Rate (ORR) (In Step 2 only) [ Time Frame: Approx. 24 months ]
  2. Disease Control Rate (DCR) at 12 months (In Step 2 only) [ Time Frame: 12 months ]
  3. Duration of Response (DR) (In Step 2 only) [ Time Frame: Approx. 24 months ]
  4. Time to deterioration (TTD) [ Time Frame: Approx. 24 months ]
  5. Time to next lung cancer therapy [ Time Frame: Approx. 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 III) unsuitable for radiotherapy or metastatic (stage IV) according to the 8th 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 After therapy with an immune checkpoint inhibitor and platinum-based chemotherapy i) either 1st line chemotherapy followed by 2nd line checkpoint inhibitor, or ii) 1st line combination of checkpoint inhibitor and chemotherapy Patients with progression during or within 12 months after the end of ICI as sequential or concomitant platinum-based chemotherapy ± radiation for locally advanced disease (stage III) are eligible
  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) at least 3 weeks prior to initiation of study treatment and have no symptoms related to brain metastases for at least 2 weeks before initiation of study treatment and are not taking any forbidden medications.
  10. Any prior chemotherapy, immunotherapy, hormonal therapy, radiation therapy or surgeries must have been completed at least 3 weeks prior to initiation of study treatment.
  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).
  2. Patients with squamous cell carcinoma histology, and who 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 that would be scheduled to continue concomitantly to the study).
  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 with a contraindication for docetaxel with grade ≥ 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80 (Tween 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 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 other active invasive cancer(s) (other than NSCLC) within 5 years prior to screening (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured (e.g.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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654587


Locations
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Sponsors and Collaborators
OSE Immunotherapeutics
More Information
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Publications:
Nemunaitis J, Cunningham, C ,Bender, J, Ishioka, G, Maples, P, Pappen, B, Stephenson, J, Morse, M, Mills, B, Greco, A, McCune, D, Steis, R, Nugent, F, Khong, HT, Richards, D. Phase II trial of a 10-epitope CTL vaccine, IDM-2101, in metastatic NSCLC patients: Induction of immune responses and clinical efficacy. International Society for Biological Therapy of Cancer 2007, p 891-2.

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Responsible Party: OSE Immunotherapeutics
ClinicalTrials.gov Identifier: NCT02654587    
Other Study ID Numbers: OSE2101C301
2015-003183-36 ( EudraCT Number )
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Keywords provided by OSE Immunotherapeutics:
Non-Small-Cell Lung Cancer
NSCLC
Immunotherapy
Cancer vaccine
Metastasis
Additional relevant MeSH terms:
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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