Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum-based Chemotherapy (TROPION-Lung05) - DS1062-A-U202 (TROPION-Lung05)

Daiichi Sankyo, Inc.0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: Daiichi Sankyo, Inc.
入组人数: 13

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（—）

入选标准

•Has pathologically documented NSCLC that
•Is stage IIIB, IIIC or stage IV NSCLC disease at the time of enrollment
•(based on the American
•Joint Committee on Cancer, Eighth Edition).
•Has 1 or more of the following documented activating genomic alterations*:
•EGFR**, ALK,
•ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
•* KRAS mutations in the absence of any of the genomic alterations specified
•above will be
•** Overexpression of EGFR, in the absence of activating mutations, is NOT
•sufficient for
•enrollment. Subjects who have not received osimertinib should be evaluated for
•the presence of
•EGFR T790M mutation after relapse/progression on/after the most recent EGFR
•tyrosine kinase
•inhibitor (TKI), unless the subject is already known to be positive with
•documented results for
•this mutation or unless osimertinib is not locally approved.
•Has 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 for advanced or metastatic NSCLC:
•Has been treated with at least 1 but no more than 2 cytotoxic
•agent-containing therapy in
•the metastatic setting:
•* One platinum-containing regimen (either as monotherapy or combination
•* May have received up to one additional line of cytotoxic agent-containing
•* Those who received a platinum-containing regimen as adjuvant therapy for
•early stage
•disease must have relapsed or progressed while on the treatment or within 6
•months of the
•last dose OR received at least one additional course of platinum-containing
•therapy (which
•may or may not be same as in the adjuvant setting) for relapsed/progressive
•May have received up to one checkpoint inhibitor (CPI)-containing regimen
•combination with a cytotoxic agent as part of a regimen described above or as
•an additional CPI
•regimen without a cytotoxic agent);
•Has been treated with 1 or more lines of non-CPI targeted therapy that is
•locally approved for
•the subject*s applicable genomic alteration at the time of screening; OR one or
•more of the
•agents specified in the table below;
•* Those who received a targeted agent for the applicable genomic alterations
•in the study as
•adjuvant therapy for early stage disease must have relapsed or progressed while
•treatment or within 6 months of the last dose OR received at least one
•additional course of
•targeted therapy for the same genomic alterations (which may or may not be same
•used in the adjuvant setting) for relapsed/progressive disease.
另有 13 项未显示

排除标准

•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 computed tomography (CT) or magnetic
•resonance imaging (MRI) scan of the brain at baseline is required for all
•subjects. For those subjects in whom central nervous system (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).
•2. Has leptomeningeal carcinomatosis.
•3. Had prior treatment with:
•a. Any chemotherapeutic agent targeting topoisomerase I, including antibody
•drug conjugate
•(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) (based on the average of screening triplicate 12-lead
•electrocardiogram 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
•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.
•g. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or
•diastolic blood pressure >110 mmHg).
•5. Has a history of non-infectious interstitial lung disease (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 Cycle 1 Day 1, severe asthma, severe
•chronic obstructive pulmonary disease, restrictive lung disease, pleural
•effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders
•with pulmonary involvement (ie, rheumatoid arthritis, Sjögren's syndrome,
•sarcoidosis, etc.), or prior pneumonectomy.
•7 Clinically significant corneal disease.
•8. Has other primary malignancies, except adequately resected non-melanoma skin
•cancer, curatively treated in situ disease, or other solid tumors curatively
•treated, with no evidence of disease for >=3 years.

研究者

发起方

Daiichi Sankyo, Inc.

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