EUCTR2021-002566-40-GR进行中（未招募）1 期
A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Amgen Inc.0 个研究点目标入组 160 人开始时间: 2021年10月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •101 Subject has provided informed consent/assent prior to initiation of
- •specific activities/procedures.
- •102 Male and female subjects >= 18 years of age (or legal adult age
- •within country) at the time of signing the informed consent.
- •103 Histologically or cytologically confirmed relapsed/refractory SCLC
- •104 Subjects who progressed or recurred following 1 platinum-based
- •regimen and at least 1 other prior line of therapy
- •Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by
- •checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as
- •maintenance therapy is considered 1 line of therapy; (3) in countries
- •where standard of care first line systemic treatment includes platinum
- •containing chemotherapy in combination with PD-L1 inhibitor, it is
- •required that patients have failed PD-L1 inhibitor as part of their first
- •line systemic treatment or are ineligible to receive PD-L1 inhibitor
- •105 Subjects willing to provide archived tumor tissue samples (formalin
- •fixed, paraffin embedded [FFPE] sample) or willing to undergo
- •pretreatment tumor biopsy. Subjects who do not have archived tumor
- •tissue available and are unable to undergo a pretreatment tumor biopsy
- •due to extenuating circumstances (eg, cannot be performed safely or
- •inaccessible, as determined by the investigator) may be allowed to enroll
- •without a tumor biopsy upon agreement between the investigator and
- •Amgen medical monitor.
- •106 Eastern Cooperative Oncology Group (ECOG) performance status of
- •107 Minimum life expectancy of 12 weeks.
- •108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to
- •dose of Tarlatamab.
- •109 Subjects with treated brain metastases are eligible provided they
- •meet the following criteria:
- •- Definitive therapy was completed at least 2 weeks prior to the first
- •dose of Tarlatamab.
- •- There is no evidence of radiographic central nervous system (CNS)
- •progression following definitive therapy and by the time of study
- •screening. Patients manifesting progression in lesions previously treated
- •with stereotactic radiosurgery may still be eligible if pseudoprogression
- •can be demonstrated by appropriate means and after discussion with the
- •medical monitor.
- •- Any CNS disease is asymptomatic for at least 7 days (unless symptoms
- •are deemed irreversible by the investigator), the patient is off steroids
- •for at least 7 days (physiologic doses of steroids are permitted), and the
- •subject is off or on stable doses of anti-epileptic drugs for malignant CNS
- •disease for at least 7 days.
- •110 Adequate organ function, defined as follows:
- •hematological function:
- •- absolute neutrophil count >= 1 x 10^9/L
- •- platelet count >= 100 x 10^9/L
- •- hemoglobin > 9 g/dL (90 g/L)
- •coagulation function:
- •- prothrombin time (PT)/international normalized ratio (INR) and partial
- •thromboplastin time (PTT) or activated partial thromboplastin time
- •(APTT) <= 1.5 x institutional upper limit of normal (ULN). Subjects on
- 另有 10 项未显示
排除标准
- •Disease Related
- •201 Untreated or symptomatic brain metastases and leptomeningeal
- •202 Has evidence of interstitial lung disease or active, non-infectious
- •pneumonitis.
- •203 Subjects who experienced recurrent pneumonitis (grade 2 or
- •higher) or severe, life-threatening immune-mediated adverse events or
- •infusion-related reactions including those that lead to permanent
- •discontinuation while on treatment with immuno-oncology agents.
- •204 Unresolved toxicity from prior anti-tumor therapy, defined as not
- •having resolved to Common Terminology Criteria for Adverse Events
- •(CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria
- •with the exception of alopecia or toxicities from prior anti-tumor therapy
- •that are considered irreversible(defined as having been present and
- •stable for > 21 day) which may be allowed if they are not otherwise
- •described in the exclusion criteria AND there is agreement to allow by
- •both the investigator and Amgen.
- •Other Medical Conditions
- •205 History of other malignancy within the past 2 years, with the
- •following exceptions:
- •- malignancy treated with curative intent and with no known active
- •present for >= 2 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician.
- •- adequately treated non-melanoma skin cancer or lentigo maligna
- •without evidence of disease.
- •- adequately treated cervical carcinoma in situ without evidence of
- •- adequately treated breast ductal carcinoma in situ without evidence of
- •- prostatic intraepithelial neoplasia without evidence of prostate cancer.
- •- adequately treated urothelial papillary noninvasive carcinoma or
- •carcinoma in situ.
- •206 Myocardial infarction and/or symptomatic congestive heart failure
- •(New York Heart Association > class II) within 12 months of first dose of
- •Tarlatamab (Section 11.9).
- •207 History of arterial thrombosis (eg, stroke or transient ischemic
- •attack) within 12 months of first dose of Tarlatamab.
- •208 Presence of fungal, bacterial, viral, or other infection requiring oral
- •or IV antimicrobials for management within 7 days of first dose
- •Tarlatamab.
- •NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial
- •pharyngitis are permitted if responding to active treatment and after
- •consultation with sponsor. Subjects requiring oral antibiotics who have
- •been afebrile > 24 hours, have no leukocytosis or have any clinical signs
- •of infection are eligible. Subjects who meet these criteria and who were
- •previously on IV antimicrobials should have been off IV antimicrobials
- •for > 48 hours.
- •209 Presence of any indwelling line or drain (eg, percutaneous
- •nephrostomy tube, indwelling Foley catheter, biliary drain, or
- •peritoneal/pericardial catheter).
- •NOTE: A pleural catheter or dedicated central venous access catheters
- •such as a Port-a-Cath or Hickman catheter are permitted.
- •XML File Identifier: HsViRNhd09w6/k16fxcMvdwgGGQ=
- 另有 10 项未显示
研究者
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