2023-509865-19-00招募中3 期
PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH OR WITHOUT ACTIONABLE GENOMIC ALTERATIONS (TROPION-LUNG01)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 261
- 试验地点
- 29
- 主要终点
- PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause.
研究概览
简要总结
To compare the efficacy of DS-1062a with that of docetaxel, as measured by PFS and OS, for subjects with NSCLC with or without actionable genomic alterations
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
- •Has the ability to provide written informed consent by signing and dating the ICF prior to the start of any study-specific qualification procedures
- •Within 7 days before randomization, has adequate hepatic function as detailed in the study protocol
- •Within 7 days before randomization, has adequate renal function, including mild or moderate renal function, as detailed in the study protocol
- •Has left ventricular ejection fraction (LVEF) ≥50% by either ECHO or MUGA scan within 28 days before randomization
- •Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN
- •Has an adequate treatment washout period before randomization, as defined in the study protocol
- •Adults ≥18 years
- •Has a life expectancy ≥3 months based on Investigator's opinion.
- •Subjects must have documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC
- •Subject must meet the following prior therapy requirements: Subjects without AGA must meet ONE of the following prior therapy requirements for advanced or metastatic NSCLC: a. Received platinum-based chemotherapy in combination with α-PD- 1/α-PD-L1 monoclonal antibody as the only prior line of therapy OR b. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy Subjects with AGA must meet the following prior therapy requirements for advanced or metastatic NSCLC: a. Has been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the subject's genomic alteration at the time of screening; OR one or more of the agents specified in the protocol b. Has received platinum-based chemotherapy as the only prior line of cytotoxic therapy c. May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination with a cytotoxic agent.
- •Must undergo a pre-treatment tumor biopsy procedure OR If available, tumor tissue previously retrieved from a biopsy procedure performed within 2 years prior to the subject signing informed consent and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the pretreatment biopsy procedure during Screening. If a documented law or regulation prohibits (or does not approve) sample collection, then such samples will not be collected/submitted.
- •Has measurable disease based on local imaging assessment using RECIST v1.1
- •Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or1 at Screening
- •Within 7 days before randomization, has adequate bone marrow function as detailed in the study protocol
排除标准
- •Has mixed small-cell lung cancer and NSCLC histology
- •Has significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
- •Clinically significant corneal disease
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
- •Has known human immunodeficiency virus (HIV) infection that is not well controlled
- •Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen [HBsAg], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization. See section 5.2 of protocol for details.
- •Has a history of malignancy, other than NSCLC except a) adequately resected non melanoma skin cancer, b) curatively treated in situ disease, or c) other solid tumors curatively treated, with no evidence of disease for ≥3 years.
- •Concomitant medical condition that would increase the risk of toxicity in the opinion of the Investigator
- •Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
- •Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel
- •History of severe hypersensitivity reactions to other monoclonal antibodies
- •Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Please see additional details in the protocol
- •Is pregnant or breastfeeding or planning to become pregnant
- •Has leptomeningeal carcinomatosis or metastasis
- •Had prior treatment with: a. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I b. TROP2-targeted therapy c. Docetaxel
- •Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease as described in Inclusion Criterion 6
- •Has NSCLC disease that is eligible for definitive local therapy alone
- •Uncontrolled or significant cardiac disease as described in detail in the protocol
- •Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement, or prior pneumonectomy
结局指标
主要结局
PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause.
PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause.
OS is defined as the time from randomization to death due to any cause.
OS is defined as the time from randomization to death due to any cause.
次要结局
- PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause.
- ORR is defined as the proportion of subjects who achieved a BOR of CR or PR.
- DoR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first.
- DCR is defined as the proportion of subjects who achieved a BOR of CR, PR, or SD.
- TTR is defined as the time from randomization to the date of the first documentation of objective response (CR or PR) in responding subjects.
研究者
Clinical Trial Office
Scientific
Daiichi Sankyo Inc.
研究点 (29)
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