EUCTR2017-002672-38-ES进行中（未招募）1 期
Open-Label, Randomized Trial of Nivolumab (BMS-936558) plus Pemetrexed/Platinum or Nivolumab plus Ipilimumab (BMS-734016) vs Pemetrexed plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects with Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed 1L EGFR Tyrosine Kinase Inhibitor Therapy - CheckMate 722: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 722
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 465
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
- •1. Signed Written Informed Consent
- •2. Target Population
- •a) Eastern Cooperative Group (ECOG) Performance Status 0-1
- •b) Subjects with histologically confirmed Stage IV or recurrent EGFR MT+ (ie, G719X,
- •L861Q, Del 19, and L858R) NSCLC (per the 7th International Association for the Study
- •of Lung Cancer classification)37 with disease progression on therapy with 1 prior EGFR
- •TKI therapy consisting of erlotinib, afatinib, or gefitinib
- •c) No evidence of exon 20 T790M mutation detected by tumor or cfDNA analysis obtained
- •at progression on prior EGFR TKI therapy. T790M testing will be confirmed centrally
- •using the cobas® EGFR Mutation Test v2 (US-IVD).
- •d) Measurable disease according to Response Evaluation Criteria in Solid Tumors version
- •1.1 (RECIST 1.1)
- •e) No prior systemic therapy for advanced or metastatic NSCLC, except for 1 prior line of
- •first- or second-generation EGFR TKI. Prior adjuvant or neoadjuvant chemotherapy for
- •early stage lung cancer is permitted as long as all toxicities have resolved or stabilized.
- •i) Prior 1L EGFR TKI therapy must have been completed at least 2 weeks prior to
- •randomization
- •ii) Switch between first- or second-generation EGFR TKI due to toxicity with no
- •evidence of disease progression is acceptable and will not be multiple lines of EGFR
- •therapy. Further questions regarding eligibility of subjects with short-term 1L TKI
- •treatment should be directed to the Medical Monitor.
- •f) Subjects must have sample available for PD-L1 IHC and exon 20 T790M testing
- •performed by the central lab during the screening period
- •i) Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor
- •tissue sections, with an associated pathology report, must be submitted for biomarker
- •evaluation prior to randomization. The tumor tissue sample may be fresh or archival
- •if obtained within 6 months prior to enrollment, and there can have been no systemic
- •therapy (eg, adjuvant or neoadjuvant chemotherapy) given after the sample was
- •ii) Tissue must be a core needle biopsy, excisional, or incisional biopsy. Fine needle
- •biopsies or drainage of pleural effusions with cytospins are not considered adequate
- •for biomarker review and randomization. Biopsies of bone lesions that do not have a
- •soft tissue component or decalcified bone tumor samples are also not acceptable
- •g) Prior palliative radiotherapy to non-CNS lesions must have been completed at least
- •2 weeks prior to randomization. Subjects with symptomatic tumor lesions at baseline that
- •may require palliative radiotherapy within 4 weeks of randomization are strongly
- •encouraged to receive palliative radiotherapy prior to randomization
- •h) Screening laboratory values must meet the following criteria (using CTCAE v4):
- •i) WBC = 2000/uL
- •ii) Neutrophils =1500/uL
- •iii) Platelet = 100x103/uL
- •iv) Hemoglobin = 9.0 g/dL
- •v) Serum creatinine = 1.5 x ULN or calculated creatinine clearance ? 50 mL/min (using
- •the Cockcroft Gault formula)
- •Female CrCl = (140 - age in years) x weight in kg x 0.85
- •72 x serum creatinine in mg/ dL
- •Male CrCl = (140 - age in years) x weight in kg x 1.0
- •72 x serum creatinine in mg/ dL
- •vi) AST = 3.0 x ULN
- •vii) ALT = 3.0 x ULN
- •viii) Total Bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome who must
- 另有 4 项未显示
排除标准
- •1. Target Disease Exceptions
- •a) Subjects with known EGFR mutation, T790M positive, detected by tumor or cfDNA
- •b) Subjects with known ALK translocations which are sensitive to available targeted
- •inhibitor therapy are excluded. If tested, use of an FDA-approved test is strongly
- •encouraged. Subjects with unknown or indeterminate ALK status may be enrolled.
- •d) Subjects with carcinomatous meningitis
- •f) Subjects with known SCLC transformation
- •g) Subjects who have progressed within 3 months of 1L EGFR TKI.
- •2. Medical History and Concurrent Diseases
- •a) Subjects must have recovered from the effects of major surgery or significant traumatic
- •injury at least 14 days before randomization.
- •b) Prior malignancy active within the previous 3 years except for locally curable cancers
- •that have been apparently cured, such as basal or squamous cell skin cancer, superficial
- •bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- •c) Subjects with an active, known or suspected autoimmune disease. Subjects with type I
- •diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders
- •(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions
- •not expected to recur in the absence of an external trigger are permitted to enroll.
- •d) 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 > 10 mg
- •daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •e) Subjects with interstitial lung disease that is symptomatic or may interfere with the
- •detection or management of suspected drug-related pulmonary toxicity.
- •g) Known history of testing positive for human immunodeficiency virus (HIV) or known
- •acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be
- •performed at sites where mandated locally
- •h) HBV carriers or those subjects receiving antiviral treatment of hepatitis B virus (HBV) or
- •hepatitis C virus (HCV)
- •i) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
- •antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or
- •checkpoint pathways
- •3. Physical and Laboratory Test Findings
- •a) Subjects with = Grade 2 peripheral neuropathy
- •b) Subjects with active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or HCV
- •(hepatitis C virus) [positive HCV RNA])
- •i) Patients with past HBV infection or resolved HBV infection (defined as the presence
- •of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. HBV
- •DNA must be obtained in these patients prior to randomization. HBV carriers or those
- •patients requiring antiviral therapy are not eligible to participate.
- •ii) Patients positive for HCV antibody are eligible only if PCR is negative for HCV
- •4. Allergies and Adverse Drug Reaction
- •a) History of allergy or hypersensitivity to platinum-containing compounds or other study
- •drug component
- •5. Other Exclusion Criteria
- •a) Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific
- •circumstances a person who has been imprisoned may be included or permitted to
- •continue as a subject. Strict conditions apply and Bristol-Myers Squibb approval is
- •b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical
- •(eg, infectious dise
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