EUCTR2015-003183-36-HU进行中（未招募）1 期
A randomized parallel group phase III trial of OSE 2101 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) - ATALANTE 1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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 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
- •a. 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
- •b. 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 (refer to section 4.3.5).
- •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).
- •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
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). 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 TKI (EGFR exon 18-21) or 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.
- •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 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/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 7
- •GUIDANCE ON CONTRACEPTION in the protocol)
- •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 7 GUIDANCE ON
- •CONTRACEPTION in the protocol)
- •18. Breastfeeding women.
- •19. Women with a positive pregnancy test.
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