2022-502357-34-00招募中3 期
A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 38
- 主要终点
- OS is defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)
研究概览
简要总结
To evaluate whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival (OS) in patients with Extended Stage Small Cell Lung Cancer (ES-SCLC).
研究设计
- 分配方式
- Randomized
- 主要目的
- Double blind treatment period
- 盲法
- Double (Analyst, Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •ECOG performance status of 0-2
- •Adequate organ function as demonstrated by the laboratory values listed in the protocol
- •Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 5.0 ≤ Grade
- •Grade 2 toxicities that would not constitute a safety risk for subsequent treatment and are not expected to resolve in a timely manner (e.g., alopecia, neuropathy, electrolyte abnormalities, immuno-oncology complications) based on the investigator’s judgement are acceptable.
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •ES-SCLC with confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
- •Progression during or after prior first- or second-line chemotherapy
- •Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Known sensitivity status (sensitive or resistant) to first- line therapy at enrollment
- •Considered to be eligible to receive topotecan chemotherapy in the Investigator’s judgment
排除标准
- •History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC.
- •Other uncontrolled serious chronic disease or psychiatric condition that in the Investigator’s opinion could affect patient safety, compliance, or follow-up in the protocol
- •Known hypersensitivity or allergy to study drugs or any component in their formulations
- •Pregnant or lactating women. Women of childbearing potential must have negative serum pregnancy test result within 7 days prior to initiating study treatment
- •Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or patients who are employees of G1 Therapeutics, Inc. directly involved in the conduct of the study
- •Concurrent participation in any other interventional clinical trial
- •Receipt of a live, attenuated vaccine within 30 days prior to the first dose of study drugs or anticipation that such a live, attenuated vaccine will be required during the study treatment period. Inactive vaccines, including but not limited to influenza vaccine, pneumococcal vaccine, shingles vaccine, and regionally approved Covid-19 vaccines are allowed.
- •Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation.
- •Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate-specific antigen [PSA] persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.
- •Any radiotherapy within 2 weeks prior to the first dose of trilaciclib/placebo.
- •Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids. Patient must be off steroids administered for brain metastases for at least 2 weeks prior to the first dose of study drugs.
- •History of ILD/pneumonitis.
- •History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥2 years or other non-clinically significant cancers (e.g., basal or squamous cell carcinoma of the skin, in situ carcinoma of the uterine cervix) which may be considered after discussion with the Medical Monitor.
- •Clinically significant (i.e., active) cardiovascular disease at the time of signing the informed consent; for example cerebrovascular accidents (≤ 6 months before the first dose of trilaciclib/placebo), myocardial infarction (≤ 6 months before the first dose of trilaciclib/placebo), unstable angina, serious cardiac arrythmia requiring medication, or uncontrolled symptomatic congestive heart failure [Class II or higher as defined by the New York Heart Association [NYHA] functional classification system])
- •QT corrected using Fridericia’s formula (QTcF) interval >480 msec at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF >500 msec
- •Known serious active infection including but not limited to, human immunodeficiency virus (HIV) (e.g., viral load indicative of HIV, HIV 1/2 antibodies), Hepatitis B (e.g., Hepatitis B surface antigen reactive or Hepatitis B DNA detected), Hepatitis C (e.g., Hepatitis C ribonucleic acid [quantitative] is detected) or tuberculosis.
结局指标
主要结局
OS is defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)
OS is defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)
次要结局
- PFS is defined as time from randomization to disease progression using RECIST v1.1 or death due to any cause, whichever occurs first; for patients without disease progression or death, PFS will be calculated per censoring rules
- ORR, as defined as the proportion of patients with confirmed CR and PR per RECIST v1.1
- Duration of objective response per RECIST v1.1
- Duration of severe (Grade 4) neutropenia in Cycle 1
- Occurrence of severe (Grade 4) neutropenia
- Occurrence of febrile neutropenia AEs
- Occurrence of G-CSF administration
- Occurrence of Grade 3 or 4 decreased hemoglobin laboratory values
- RBC transfusions on or after Week 5 (occurrence and number of transfusions)
- Occurrence of ESA administration
- Occurrence of Grade 3 or 4 decreased platelet count laboratory values
- Platelet transfusions (occurrence and number of transfusions)
- Occurrence and number of hospitalizations due to chemotherapy-induced myelosuppression
- All-cause dose reductions (occurrence and number of reductions)
- All-cause cycle delays (occurrence and number of delays)
- Occurrence and severity of AEs by NCI CTCAE v5.0
- Occurrence of study treatment discontinuation due to AEs
- Occurrence of Trilaciclib AESIs
- Occurrence of Grade 3 or 4 abnormalities in serum chemistry laboratory parameters
- Occurrence of trilaciclib infusion interruptions
- Occurrence of topotecan infusion interruptions
- Relative dose intensity of topotecan
研究者
Lars Lykke Thomsen
Scientific
Pharmacosmos A/S
研究点 (38)
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