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临床试验/EUCTR2015-003183-36-DE
EUCTR2015-003183-36-DE进行中（未招募）1 期

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) - ATALANTE 1

OSE Immunotherapeutics0 个研究点目标入组 494 人开始时间: 2016年5月2日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
494
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Protection of study subjects and compliance
  • •1. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) 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.
  • •Cancer Diagnosis and treatment
  • •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:
  • •- either 1st line chemotherapy followed by 2nd line checkpoint inhibitor,
  • •- or 1st line combination of checkpoint inhibitor and chemotherapy
  • •Patients with progression during or within 12 months after the end of ICI as sequential 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 (see Section 4.3.5 of the protocol).
  • •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).
  • •Clinical status
  • •12. ECOG performance status 0-1.
  • •13. Adequate organ function as defined by all the following criteria:
  • •a. Albuminemia > 25g/L
  • •b. 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
  • •c. Total serum bilirubin = 1.5 x ULN
  • •d. Absolute neutrophil count (ANC) = 1500/microliters
  • •e. Platelets 100000/microliters
  • •f. Hemoglobin = 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization)
  • •g. Creatinine clearance (based on modified Cockcroft-Gault formula) =
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 312
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 182

排除标准

  • •Cancer Diagnosis and treatment
  • •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 their prior chemotherapy will not be eligible for this trial.
  • •3. Current or previous treatment with investigational therapy in another
  • •therapeutic clinical trial i(interrupted less than 4 weeks before study
  • •treatment initiation).
  • •4. Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to TKI (EGFR exon 18-21) or 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.
  • •Medical history and clinical status
  • •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/orsponsor, 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 (See APPENDIX 4
  • •GUIDANCE ON CONTRACEPTION)
  • •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 (See APPENDIX 4 GUIDANCE O

研究者

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