A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib versus Placebo in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated with Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4)

G1 Therapeutics, Inc.0 个研究点目标入组 146 人开始时间: 2021年8月5日最近更新: 2022年5月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: G1 Therapeutics, Inc.
入组人数: 146

研究概览入排标准研究者记录与标识符相似试验

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. Age =18 years of age at the time of signing the informed consent
•2. Histologically or cytologically confirmed metastatic NSCLC (squamous or nonsquamous) with no known actionable driver mutations (ex. EGFR, ROS1, ALK):
•o Patients must have had documented disease progression during or after 1 or 2 lines of systemic treatment for recurrent or metastatic disease
•o Two components of treatment must have been received in the same line or as separate lines of therapy: (i) a maximum of 1 line of platinum-containing chemotherapy regimen for recurrent/metastatic disease, and (ii) a maximum of 1 line of a locally approved/authorized PD-1/PD-L1 mAb containing regimen for recurrent/metastatic disease
•o Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate line of therapy. Maintenance therapy is defined as therapy given within 42 days after the last dose of platinum-based chemotherapy in patients with ongoing clinical benefit (complete response [CR], partial response [PR] or stable disease [SD]).
•3. Measurable or non-measurable disease per RECIST v1.1
•4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
•5. A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting NSCLC must be available to send to the Sponsor, within the specified timeframe, for planned retrospective biomarker analyses
•6. Adequate organ function defined by the following laboratory values:
•a) Hemoglobin =9.0 g/dL in the absence of red blood cell transfusion or erythropoiesis stimulating agent administration within 14 days prior to first dose of trilaciclib/placebo
•b) Absolute neutrophil count (ANC) =1.5 × 10^9/L
•c) Platelet count =100 × 10^9/L
•d) Total bilirubin = upper limit of normal (ULN)
•e) AST/ALT <1.5 × ULN if alkaline phosphatase >2.5 × ULN
•f) If alkaline phosphatase <2.5 × ULN then AST, ALT <2.5 x ULN in the absence of liver metastasis or <5 × ULN in the presence of liver metastasis
•g) Estimated glomerular filtration rate =30 mL/minute/1.73m2
•7. Resolution of nonhematologic toxicities per National Cancer Institute Common Terminology Criteria Version 5.0 (NCI-CTCAE) from prior therapy or surgical procedures to = Grade 1 or baseline (except alopecia)
•8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
•9. 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 146
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

排除标准

•1. Prior therapy with docetaxel
•2. Any contraindication to the administration of docetaxel at the discretion of the investigator
•3. Mixed NSCLC/SCLC, or lung tumors whose predominant histology is sarcomatoid, or neuroendocrine
•4. 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
•5. Any radiotherapy within 2 weeks prior to the first dose of trilaciclib/placebo
•6. Presence of central nervous system (CNS) metastases requiring immediate treatment with radiation therapy or steroids (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo)
•7. Presence of leptomeningeal disease
•8. Significant third-space fluid retention (ex. ascites or pleural effusion) not amenable to required repeat drainage
•9. QT corrected using Fridericia’s formula (QTcF) interval >480 msec at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF >500 msec
•10. Symptomatic peripheral neuropathy (= Grade 2 NCI-CTCAE v5.0)
•11. History of interstitial lung disease (ILD)
•12. 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])
•13. 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., HBsAg reactive or HBV DNA detected), Hepatitis C (e.g., HCV RNA [quantitative] is detected) or tuberculosis
•14. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation
•15. Receipt of any low-dose systemic chemotherapeutic agent (e.g., low-dose methotrexate for rheumatoid arthritis) administered for a nononcologic purpose within 3 weeks prior to the first dose of trilaciclib/placebo
•16. Receipt of any live attenuated vaccines within 4 weeks prior to first dose of study treatment or anticipation that such a vaccine will be required during the study treatment period
•17. Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80 or any excipients of trilaciclib
•18. Pregnant or lactating women
•19. Legal incapacity or limited legal capacity
•20. 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
•21. Concurrent participation in any other interventional clinical trial

研究者

发起方

G1 Therapeutics, Inc.

相似试验

进行中（未招募）

1 期

A study to evaluate the effect of trilaciclib on overall survival in patients with metastatic non-small cell lung cancer receiving docetaxelMetastatic Non small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2021-000186-32-ITG1 Therapeutics Inc.146

进行中（未招募）

1 期

EUCTR2021-000186-32-ESG1 Therapeutics, Inc.146

招募中

1 期

A Phase 2, Double-Blind, Randomized Clinical Trial to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extensio

CTIS2022-502298-41-00Praxis Precision Medicines Inc.20

招募中

1 期

Phase 2 Study of Adjuvant V940 and Pembrolizumab in Renal Cell CarcinomaIntermediate-high -risk RCC, high-risk RCC who have undergone nephrectomy, or M1 NED RCC who have undergone nephrectomy and metastasectomy.MedDRA version: 21.1Level: PTClassification code: 10067946Term: Renal cell carcinoma Class: 100000004864

CTIS2023-505177-32-00Merck Sharp & Dohme LLC296

进行中（未招募）

不适用

A Phase 2a, Double-Blind, Placebo Controlled Trial of the Efficacy, Safety and Tolerability of 6-Weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease.MedDRA version: 12.1Level: LLTClassification code 10007864Term: Celiac diseaseCeliac Disease

EUCTR2010-023127-23-FIAlvine Pharmaceuticals, Inc.55