NL-OMON48833已完成不适用
PD-L1 PET/CT to predict avelumab treatment response in NSCLC - PD-L1 imaging in NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
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 64（—）
入选标准
- •1. Male or female subjects aged * 18 years and >50 years in patients with
- •resectable stage Ia (*T1b tumor) - IIIa NSCLC
- •2. Histological or cytologic proven stage IIIb/IV NSCLC or resectable stage Ia
- •(*T1b tumor) - IIIa NSCLC
- •3. ECOG performance score (0-1)Karnofsky performance score * 70
- •4. At least one lesion with a tumor size * 1 cm
- •5. Hematologic function: absolute neutrophil count (ANC) * 1.5 × 109/L,
- •platelet count * 100 × 109/L, and hemoglobin * 9 g/dL (may have been transfused)
- •6. Hepatic function: total bilirubin level * 1.5 × the upper limit of normal
- •(ULN) range and AST and ALT levels * 2.5 × ULN for all subjects or AST and ALT
- •levels * 5 x ULN (for subjects with documented metastatic disease to the liver).
- •7. Estimated creatinine clearance * 30 mL/min according to the Cockcroft-Gault
- •formula (or local institutional standard method)
- •8. Highly effective contraception for both male and female subjects throughout
- •the study and for at least 60 days after avelumab treatment administration if
- •the risk of conception exists. (Note: The effects of the trial drug on the
- •developing human foetus are unknown; thus, women of childbearing potential and
- •men able to father a child must agree to use 2 highly effective contraception,
- •defined as methods with a failure rate of less than 1 % per year. Highly
- •effective contraception is required at least 28 days prior, throughout and for
- •at least 60 days after avelumab treatment.)
- •9. Fit for surgery (for patients with resectable stage Ia-IIIa disease), as
- •assessed by treating thoracic surgeon / anesthesiologists based on sufficient
- •cardiopulmonary status and absence of major contra-indications for surgery
- •according to local guidelines
排除标准
- •1. All subjects with brain metastases, except those meeting the following
- •* Brain metastases that have been treated locally and are clinically stable for
- •at least 2 weeks prior to enrollment
- •* No ongoing neurological symptoms that are related to the brain localization
- •of the disease (sequelae that are a consequence of the treatment of the brain
- •metastases are acceptable)
- •* Subjects must be either off steroids or on a stable or decreasing dose of <
- •10mg daily prednisone (or equivalent)
- •2. Prior organ transplantation, including allogeneic stem cell transplantation
- •3. Significant acute or chronic infections including, among others:
- •* Active infection requiring systemic therapy
- •* Known history of testing positive test for human immunodeficiency virus (HIV)
- •or known acquired immunodeficiency syndrome (AIDS)
- •* Positive test for HBV surface antigen and / or confirmatory HCV RNA (if
- •anti-HCV antibody tested positive)
- •4. Active autoimmune disease that might deteriorate when receiving an
- •immunostimulatory agent:
- •-. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
- •disease not requiring immunosuppressive treatment are eligible
- •5. Hypersensitivity to study drug: *Known prior severe hypersensitivity
- •reactions to investigational product or any component in its formulations,
- •including known severe hypersensitivity reactions to antibodies (Grade * 3 NCI
- •CTCAE v 4.03)
- •6. Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03;
- •however, alopecia and sensory neuropathy Grade * 2 is acceptable
- •7. Pregnancy or lactation
- •8. Known alcohol or drug abuse
- •9. Other severe acute or chronic medical conditions including colitis,
- •inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric
- •conditions including recent (within the past year) or active suicidal ideation
- •or behavior; or laboratory abnormalities that may increase the risk associated
- •with study participation or study treatment administration or may interfere
- •with the interpretation of study results and, in the judgment of the
- •investigator, would make the patient inappropriate for entry into this study.
- •10. Any psychiatric condition that would prohibit the understanding or
- •rendering of informed consent
- •11. Vaccination within 4 weeks of the first dose of avelumab and while on trial
- •is prohibited except for administration of inactivated vaccines
- •12. Immunosuppressants: *Current use of immunosuppressive medication, EXCEPT
- •for the following: a. intranasal, inhaled, topical steroids, or local steroid
- •injection (eg, intra-articular injection); b. Systemic corticosteroids at
- •physiologic doses * 10 mg/day of prednisone or equivalent; c. Steroids as
- •premedication for hypersensitivity reactions (eg, CT scan premedication).*
- •13. Cardiovascular disease: *Clinically significant (i.e., active)
- •cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to
- •enrollment), myocardial infarction (< 6 months prior to enrollment), unstable
- •angina, congestive heart failure (* New York Heart Association Classification
- •Class II), or serious cardiac arrhythmia requiring medication.*
- •14. Prior anti-PD-1 or anti-PD-L1 therapy
研究者
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