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Trial record 1 of 1 for:    OSE2101C301
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654587
Recruitment Status : Recruiting
First Posted : January 13, 2016
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
OSE Immunotherapeutics

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 13, 2016
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
Overall Survival time (OS) [ Time Frame: Approximatively 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • Disease Control Rate (DCR) at 6 months [ Time Frame: 6 months ]
  • QLQ-C30 (EORTC QLQ questionnaire): "Global health status/QoL" score based on questions 29 [ Time Frame: Approx. 24 months ]
  • 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 ]
  • Progression Free Survival (PFS) [ Time Frame: Approx. 24 months ]
  • Objective Response Rate (ORR) (in Step 1 only) [ Time Frame: Approx. 24 months ]
  • DCR at 12 months (in Step 1 only) [ Time Frame: Approx. 24 months ]
  • Duration of Response (DR) (in Step 1 only) [ Time Frame: Approx. 24 months ]
  • Safety and tolerability profile compared to the control group [ Time Frame: Approx. 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2019)
  • Objective Response Rate (ORR) (In Step 2 only) [ Time Frame: Approx. 24 months ]
  • Disease Control Rate (DCR) at 12 months (In Step 2 only) [ Time Frame: 12 months ]
  • Duration of Response (DR) (In Step 2 only) [ Time Frame: Approx. 24 months ]
  • Time to deterioration (TTD) [ Time Frame: Approx. 24 months ]
  • Time to next lung cancer therapy [ Time Frame: Approx. 24 months ]
Original Other Pre-specified Outcome Measures
 (submitted: January 12, 2016)
  • 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
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: OSE2101
    Other Names:
    • Tedopi
    • EP-2101
    • EP2101
    • IDM-2101
  • Drug: Docetaxel
    Other Name: Taxotere
  • Drug: Pemetrexed
    Other Name: Alimta
Study Arms  ICMJE
  • 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).
    Intervention: Drug: OSE2101
  • 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.

    Interventions:
    • Drug: Docetaxel
    • Drug: Pemetrexed
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2019)
363
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
500
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bérangère Vasseur, MD berangere.vasseur@ose-immuno.com
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02654587
Other Study ID Numbers  ICMJE OSE2101C301
2015-003183-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OSE Immunotherapeutics
Study Sponsor  ICMJE OSE Immunotherapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account OSE Immunotherapeutics
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP