2025-525026-35-00招募中3 期
A phase III, randomised, double-blind, placebo-controlled, multicentre trial comparing efficacy and safety of trilaciclib versus placebo in participants with limited-stage small cell lung cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- • Duration of severe neutropenia in cycle 1
研究概览
简要总结
To compare trilaciclib to placebo on prevention of myelosuppression in participants with LS-SCLC undergoing CRT
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Subject, Carer, Monitor, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Women and men aged ≥18 years
- •Confirmed diagnosis of SCLC by histology or cytology with clinical and pathologic staging that confirms limited stage (according to VALSG or AJCC/UICC 8th edition – Stage I-III) with the absence of distant metastases
- •ECOG performance status of 0 or 1
- •Eligible to receive concurrent CRT
- •Measurable or evaluable disease as defined by RECIST guideline version 1.1
- •Adequate organ functioning as demonstrated by the following laboratory values: • Hb ≥9 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of IMP • ANC ≥1.5 × 109/L • Platelet count ≥100 × 109/L • eGFR ≥ 60 mL/minute/1.73 m2 • Total bilirubin ≤1.5 × ULN (<3 × ULN if Gilbert’s disease) • ALT and AST ≤2.5 × ULN • Albumin ≥3 g/dL
- •Complete recovery from prior anti-tumour surgical procedures
- •Acceptance of using contraceptives as described in Section 16 or where local regulations impose stricter requirements for contraception, those stricter requirements apply
- •Willingness to participate and signing the ICF
排除标准
- •Pregnant or nursing women
- •Receipt of a live, attenuated vaccine within 30 days prior to the first dose of IMP or anticipation that such a live, attenuated vaccine will be required during the trial 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 haematopoietic stem cell or bone marrow transplantation
- •Any laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the participant’s disease management at risk or may result in the participant being unable to comply with the trial requirements
- •History of cisplatin, carboplatin, etoposide, or trilaciclib treatment for SCLC
- •Any chemotherapy, radiotherapy, 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 persistence/recurrence without metastatic disease) within 3 weeks prior the first dose of trilaciclib/placebo
- •History of grade ≥2 interstitial lung disease/pneumonitis (except for resolved infective pneumonia)
- •History of other malignancies, except for curatively treated solid tumours with no evidence of disease for ≥2 years or other non-clinically significant cancers (e.g., basal or squamous cell carcinoma of the skin and 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 ICF, e.g., 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 NYHA)
- •QTcF interval >480 msec at screening (confirmed on repeat). For participants with ventricular pacemakers, QTcF >500 msec
- •Known serious active infection including but not limited to, HIV (e.g., viral load indicative of HIV and HIV 1/2 antibodies), hepatitis B (e.g., hepatitis B surface antigen reactive or hepatitis B DNA detected), hepatitis C (e.g., hepatitis C RNA detected) or tuberculosis
- •Known hypersensitivity or allergy to trilaciclib, cisplatin, carboplatin, or etoposide or any component in their formulations
结局指标
主要结局
• Duration of severe neutropenia in cycle 1
• Duration of severe neutropenia in cycle 1
• Occurrence of severe neutropenia
• Occurrence of severe neutropenia
次要结局
- Efficacy • Number of all-cause chemotherapy dose reductions
- • Occurrence of granulocyte colony-stimulatingfactor (G-CSF) administration
- • Number of hospitalisations due to myelosuppression or sepsis
- • Number of febrile neutropenia (grade 3 or 4)
- • Occurrence of red blood cell (RBC) transfusions on/after week 5
- • ORR per response evaluation criteria in solid tumours (RECIST) guideline version 1.1
- • BOR per RECIST guideline version 1.1
- • Duration of severe neutropenia in cycle 2
- • Duration of severe neutropenia in cycle 2 through 4
- • Number of all-cause interruptions of radiotherapy
- • Occurrence of radiotherapy-induced toxicities mucositis and/or esophagitis
- • Occurrence of all-cause chemotherapy dose reductions
- • Number of chemotherapy dose reductions in cycle 4
- • Occurrence of all-cause cycle delays
- • Number of all-cause cycle delays
- • Occurrence of hospitalisations due to myelosuppression or sepsis
- • Occurrence of febrile neutropenia (grade 3 or 4)
- • Occurrence of grade 3 or 4 haematologic toxicities (absolute neutrophil count [ANC], haemoglobin [Hb], and platelet counts)
- • Occurrence of platelet transfusions
- • Occurrence of erythropoiesis-stimulating agent (ESA) administrations
- • Occurrence of systemic antimicrobial therapy
- • Change in Functional Assessment of Cancer Therapy-Lung (FACT-L, total score, subscale domains, and Trial Outcome Index [TOI]) from baseline to day 1 of cycles 2–4, days 10 and 17 of each cycle, end-of-treatment, and follow-up at day 90
- • Time to deterioration in FACT-L total score, subscale domains, and TOI
- • Change in Functional Assessment of Cancer Therapy-Anaemia (FACT-An, total score, subscale domains, and TOI) from baseline to day 1 of cycles 2–4, days 10 and 17 of each cycle, end-of-treatment, and follow-up at day 90
- • Time to deterioration in FACT-An total score, subscale domains, and TOI
- Safety • Type and occurrence of adverse events (AEs)
- • Type and occurrence of adverse events of safety focus area (AESFA)
- • Time from baseline to onset of first AESFA
- • Time from last trilaciclib dose to onset of any AESFA
- • Duration of AESFA
- • Occurrence of grade 3 or 4 clinical chemistry toxicities
- • Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, vital signs, weight, electrocardiogram (ECG), and safety laboratory tests will be measured as part of standard safety assessments
研究者
Lars Lykke Thomsen
Scientific
Pharmacosmos A/S
研究点 (16)
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