JPRN-jRCT2031200449招募中1 期
A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Durvalumab with or without Carboplatin in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer - TROPION-Lung04
Hibi Kazushige0 个研究点目标入组 68 人开始时间: 2021年3月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
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
- •Men or women >=20 years old in Japan, >=18 years old in the other countries on the day of signing the informed consent form (for the other countries, local regulatory requirements to consent should be followed).
- •- Advanced or metastatic NSCLC, histologically confirmed at diagnosis of NSCLC, documented negative test results for EGFR and ALK genomic alterations, and no known genomic alterations in ROS1, NTRK, BRAF, RET, MET, or other actionable driver kinases with approved therapies (actionable genomic alterations).
- •- Is not a candidate for surgical resection or chemoradiation with curative intent.
- •- Documentation of radiological disease progression while on or after receiving the most recent treatment regimen, if any, for advanced or metastatic NSCLC.
- •- Must be treatment-naive or have received only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors (ICIs) including anti- PD-1/PD-L1, anti-PD-L2, and anti-CTLA-4 for advanced or metastatic NSCLC.
- •- Willing and able to undergo a mandatory tumor biopsy. There is no requirement for PD-L1 protein expression for inclusion.
- •- Archival tumor tissue from initial diagnosis, to the extent that archival tumor tissue is available, for measurement of TROP2 expression levels or other biomarkers.
- •- Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 Day 1.
排除标准
- •- Experienced grade 3 or higher immune-related adverse events with prior immunotherapy treatment.
- •- Received a live vaccine within 30 days prior to the first dose of study treatment.
- •- Active, known, or suspected autoimmune disease.
- •- Has a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day 1.
- •- Prior allogenic organ transplantation.
- •- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or durvalumab, and carboplatin for participants to be enrolled in relevant cohorts.
- •- Uncontrolled or significant cardiac disease.
- •- 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.
- •- 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.
- •- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- •- History of another primary malignancy, (beyond NSCLC) except for:
- •1.Malignancy treated with curative intent and with no known active disease >=3 years before the first dose of study treatment and of low potential risk for recurrence.
- •2.Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •3.Adequately treated carcinoma in situ without evidence of disease.
- •4.Participants with a history of prostate cancer.
- •- Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 Grade <=1 or baseline.
研究者
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