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临床试验/NL-OMON37458
NL-OMON37458已完成3 期

An Open-label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) - CA209-017

Bristol-Myers Squibb0 个研究点目标入组 10 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
10
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

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1. Signed written informed consent
  • •2. Men and women >= 18 years of age
  • •3. Eastern Cooperative Oncology Group (ECOG) performance status of <= 1
  • •4. Subjects with histologically or cytologically-documented squamous cell NSCLC who present
  • •with Stage IIIB/ Stage IV disease or recurrent disease following radiation therapy or surgical resection.
  • •5. Subjects must have experienced disease recurrence or progression during or after one prior
  • •platinum-containing doublet chemotherapy regimen for advanced or metastatic disease
  • •a. Subjects who received erlotinib as maintenance therapy (non-progressors with
  • •platinum-based doublet chemotherapy) and progressed are eligible. However,
  • •subjects who received a tyrosine kinase inhibitor after failure of a prior platinum based therapy are excluded
  • •b. Subjects who received adjuvant or neoadjuvant platinum-doublet chemotherapy
  • •(after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible.
  • •c. Subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum based
  • •chemotherapy, who also subsequently progressed during or after a platinum doublet
  • •regimen given to treat the recurrence, are eligible.
  • •6. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria; Radiographic
  • •Tumor Assessment performed within 28 days of randomization. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
  • •7. A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor
  • •sample (archival or recent) must be available for biomarker evaluation. Biopsy
  • •should be excisional, incisional or core needle. Fine needle aspiration is insufficient.
  • •8. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests including completion of patient reported outcomes questionnaires and other requirements of the study.
  • •9. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria
  • •i) WBCs >= 2000/µL
  • •ii) Neutrophils >= 1500/µL
  • •iii) Platelets >= 100 x 10³/µL
  • •iv) Hemoglobin >= 9.0 g/dL
  • •v) Serum creatinine of <= 1.5 X ULN or creatinine clearance > 40 mL/minute
  • •(using Cockcroft/Gault formula)
  • •vi) AST <= 1.5X ULN
  • •vii) ALT <= 1.5X ULN
  • •viii) Total bilirubin <= ULN (except subjects with Gilbert Syndrome who must have total bilirubin <3.0 mg/dL)
  • •10. Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
  • •11. Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 2 of the protocol. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception should be determined in consultation with the investigator.
  • •WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product.
  • •Women must not be breastfeeding during the trial;12. Men who are sexually active with WOCBP must use any contraceptive method with a failure r

排除标准

  • •1. Subjects with active CNS metastases are excluded. Subjects are eligible if CNS mets are adequately treated and subjects are neurologically returned to baseline (except for residual
  • •signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In
  • •addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <= 10
  • •mg daily prednisone (or equivalent).
  • •2. Subjects with carcinomatous meningitis
  • •3. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I
  • •diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring
  • •hormone replacement, or conditions not expected to recur in the absence of an external trigger
  • •are permitted to enroll.
  • •4. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg
  • •daily prednisone equivalent) or other immunosuppressive medications within 14 days of
  • •randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg
  • •daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • •5. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
  • •(including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • •6. Prior treatment on the first-line study CA184104
  • •7. Prior treatment with docetaxel
  • •8. Subjects with a history of interstitial lung disease
  • •9. Other active malignancy requiring concurrent intervention
  • •10. Subjects with previous malignancies (except non-melanoma skin cancers, and the following
  • •in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast)
  • •are excluded unless a complete remission was achieved at least 2 years prior to study entry
  • •AND no additional therapy is required during the study period
  • •11. Treatment with any investigational agent within 28 days of first administration of study
  • •12. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
  • •13. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment
  • •14, Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • •15. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
  • •16. History of severe hypersensitivity reactions to other monoclonal antibodies.
  • •17. History of severe hypersensitivity reaction to prior paclitaxel
  • •18. History of allergy or intolerance (unacceptable adverse event) to study drug components or Polysorbate-80-containing infusions.
  • •19. WOCBP who are pregnant or breastfeeding
  • •20. Women with a positive pregnancy test at enrolment or prior to administration of study medication
  • •21. Ongoing or planned administration of anti-cancer therapies other than those specified in this study
  • •22. Use of corticosteroids or other immunosuppressive medications as per Exclusion Criteria 2b
  • •23. Strong CYP3A4 inhibitors (See Section 3.4.1 of the protocol)
  • •24. Any other serious or uncontrolled medical dis

研究者

发起方
Bristol-Myers Squibb

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