JPRN-jRCT2031200186进行中（未招募）2 期
A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFRmutated Non-Small Cell Lung Cancer (NSCLC) - HERTHENA-Lung01 - HERTHENA-Lung01
Inoguchi Akihiro0 个研究点目标入组 420 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Sign and date the tissue ICF and the main ICF, prior to the start of any study-specific qualification procedures.
- •Male or female participants aged >=18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
- •Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.
- •Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Participants must have received both of the following:
- •Prior treatment with osimertinib. Participants receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. Participants in South Korea known to harbor a clinically actionable genomic alteration in addition to EGFR mutation (e.g., anaplastic lymphoma kinase [ALK] or ROS1 protocol oncogene 1 [ROS1] fusion) for which treatment is available must have also received prior treatment with at least 1 approved genotype-directed therapy, unless unable (i.e., if contraindicated). No new testing for these genomic alterations (e.g., ALK or ROS1 fusion) is required for Screening.
- •Systemic therapy with at least 1 platinum-based chemotherapy regimen.
- •Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.
- •At least 1 measurable lesion confirmed by BICR as per RECIST v1.1
- •Consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content. Required tumor tissue can be provided as either:
- •Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy OR
- •Archival tumor tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on or after treatment with the most recent cancer therapy regimen.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
- •Has adequate bone marrow reserve and organ function as defined by the protocol within 14 days prior to Cycle 1 Day 1.
- •Platelet count : >=100,000/mm^3 or >=100 x 10^9/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility)
- •Hemoglobin: >=9.0 g/dL (transfusion and/or growth factor support is allowed)
- •Absolute neutrophil count: >=1500/mm^3 or >=1.5 x 10^9/L
- •Serum creatinine (SCr) or creatinine clearance (CrCl): SCr <=1.5 x upper limit of normal (ULN), OR CrCl >=30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl
- •Aspartate aminotransferase/alanine aminotransferase: <=3 x ULN (if liver metastases are present, <=5 x ULN)
- •Total bilirubin: <=1.5 x ULN if no liver metastases (<3 x ULN in the presence of documented Gilbert's syndrome [unconjugated hyperbilirubinemia] or liver metastases)
- •Serum albumin: >=2.5 g/dL
- •Prothrombin time (PT) or PT-International normalized ratio (INR) and activated partial thromboplastin time (aPTT)/PTT: <=1.5 x ULN, except for subjects on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator
排除标准
- •Any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy.
- •Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis), has current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screening.
- •Clinically severe respiratory compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
- •Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months prior to the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD]), restrictive lung disease, pleural effusion);
- •Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior complete pneumonectomy.
- •Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
- •Evidence of any leptomeningeal disease.
- •Evidence of clinically active spinal cord compression or brain metastases,
- •Inadequate washout period prior to Cycle 1 Day 1, defined as:
- •Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days;
- •Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), <14 days or 5 half-lives, whichever is longer;
- •Monoclonal antibodies, other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) <28 days;
- •Immune checkpoint inhibitor therapy <21 days;
- •Major surgery (excluding placement of vascular access) <28 days;
- •Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days; or
- •Chloroquine or hydroxychloroquine <14 days.
- •Prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody or single-agent topoisomerase I inhibitor.
- •Prior treatment with an antibody drug conjugate (ADC) that consists of any topoisomerase I inhibitor
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade <=1 or baseline. Participants with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.
- •Has history of other active malignancy within 3 years prior to enrollment, except:
- •Adequately treated non-melanoma skin cancer;
- •Superficial bladder tumors (Ta, Tis, T1);
- •Adequately treated intraepithelial carcinoma of the cervix uteri;
- •Low risk non-metastatic prostate cancer (with Gleason score <7, and following local treatment or ongoing active surveillance);
- •Any other curatively treated in situ disease.
- •Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1
- •Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1.
- •Participant with any human immunodeficiency virus (HIV) infection.
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