Phase 2, Single-arm, Open-label Study of DS1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed on or After Applicable Targeted Therapy and Platinumbased Chemotherapy (TROPION-Lung05) - DS1062-A-U202

Daiichi Sankyo Inc.0 个研究点目标入组 24 人开始时间: 2024年6月17日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Daiichi Sankyo Inc.
入组人数: 24

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

入排标准

年龄范围: 18 至 64（—）
性别: All

入选标准

•Subjects must meet all of the following criteria to be eligible for enrollment into the study: 1. Sign and date the ICF prior to the start of any study- specific qualification procedures., 10. Within 7 days before Cycle 1 Day 1, has adequate bone marrow function defined as: a. Platelet count =100,000/mm3 (platelet transfusion is not allowed within 1 week prior to screening assessment). b. Hemoglobin =9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment). c. Absolute neutrophil count =1500/mm3 (granulocyte-colony stimulating factor [G-CSF] administration is not allowed within 1 week prior to screening assessment).(See sections 6.5 and 6.7 for use of G-CSF and erythropoietin), 11. Within 7 days before Cycle 1 Day 1, has: - Adequate hepatic function, defined as: ? Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 × upper limit of normal (ULN) or AST/ALT =5.0 x ULN if transferase elevation is due to liver metastases). ? Total bilirubin (TBL) =1.5 × ULN or <3.0 mg/dL in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia). OR ? Moderate hepatic dysfunction (a maximum of 9 subjects): TBL >1.5 × ULN and =3 × ULN and any AST. Note: After a maximum of 9 subjects with mild or moderate hepatic dysfunction have been enrolled, subsequent subjects with moderate hepatic dysfunction will be excluded., 12. Within 7 days before Cycle 1 Day 1, has adequate renal function, including mild or moderate renal function, defined as: - Creatinine clearance =30 mL/min, as calculated using the Cockcroft-Gault equation., 13. Has a left ventricular ejection fraction (LVEF) =50% by either an ECHO or MUGA scan within 28 days before Cycle 1 Day 1., 14. Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin =1.5 × ULN within 7 days before enrollment., 15. Has an adequate treatment washout period before Cycle 1 Day 1 defined as: -Major surgery: =3 weeks -Radiation therapy (curative) and palliative radiation to the chest: = 4 weeks = 2 weeks (palliative radiation therapy to other areas) [ie, limited field and 10 or fewer days or fractions] including whole brain radiotherapy) -Anti-cancer chemotherapy (immunotherapy [non-antibody-based therapy]), retinoid therapy: =2 weeks or 5 times the t1/2 of the chemotherapeutic agent, whichever is longer; =6 weeks for nitrosoureas or mitomycin C, =1 week for TKIs approved for the treatment of NSCLC - baseline CT scan should be completed after discontinuation of TKI -Antibody-based anti-cancer therapy: =4 weeks -Chloroquine/Hydroxychloroquine: >14 days, 16. Has a life expectancy =3 months based on investigator's opinion. Please refer to the protocol for full list of inclusion criteria., 2. Adults =18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)., 3. Has pathologically documented NSCLC that: a. Is stage IIIB, IIIC or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition). b. Has one or more of the following documented activating tumor genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping or RET., 4. Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC., 5. Subject must meet at least the

排除标准

•Subjects who meet any of the following criteria will be disqualified from entering the study: 1. Has spinal cord compression or clinically active central nervous system 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. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment. Note: A CT or magnetic resonance imaging (MRI) scan of the brain at baseline is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator should consider delay of study treatment to document stability of CNS metastases with repeat imaging at least 4 weeks later (in which case, repeat of all screening activity may be required)., 10. 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], antihepatitis B surface antigen [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA) and/or hepatitis C infection (as per HCV RNA) within 28 days of Cycle 1 Day 1. Please refer to the protocol for full list of exclusion criteria., 2. Has leptomeningeal carcinomatosis., 3. Prior treatment with: a. Any chemotherapeutic agent targeting topoisomerase I, including ADC containing such agent. b. TROP2-targeted therapy., 4. Uncontrolled or significant cardiovascular disease, including: a. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 milliseconds (msec) for females or >450 msec for males (based on the average of screening triplicate 12-lead ECG determinations). b. History of myocardial infarction within 6 months prior to Cycle 1 Day 1. c. History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1. d. Symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) at screening. Subjects with a history of Class II to IV CHF prior to screening, must have returned to class I CHF and have LVEF =50% (by either an ECHO or MUGA scan within 28 days of Cycle 1 Day 1) in order to be eligible. e. History of serious cardiac arrhythmia requiring treatment. f. LVEF <50% or institutional lower limit of normal by ECHO or MUGA scan. within 28 days before Cycle 1 Day 1. g. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before Cycle 1 Day 1., 5. 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., 6. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammator

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发起方

Daiichi Sankyo Inc.

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