BENITIONSClinical Trial Intelligence

Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs

2期 进行中(已停止招募) NCT03896503

适应症Extensive Stage Lung Small Cell Carcinoma, Extrapulmonary Small Cell Neuroendocrine Carcinoma, Limited Stage Lung Small Cell Carcinoma, Platinum-Resistant Lung Small Cell Carcinoma
分期2期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数104 人
干预(药物)Berzosertib, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Topotecan Hydrochloride
开始日期2019年12月30日
完成日期2022年12月19日
结果公布日2024年11月13日

摘要

This phase II trial studies how well berzosertib (M6620) works when given in combination with topotecan hydrochloride (topotecan) compared with topotecan alone in treating patients with small cell lung cancer that has come back (relapsed), or small cell cancer that arises from a site other than the lung (extrapulmonary). Drugs used in chemotherapy, such as topotecan hydrochloride, work by damaging the DNA (deoxyribonucleic acid) in tumor cells, causing those cells to die and the tumor to shrink. However, some tumor cells can become less affected by chemotherapy because they have ways to repair the damaged DNA. The addition of M6620 could help topotecan hydrochloride shrink the cancer and prevent it from returning by blocking enzymes needed for DNA repair.

Progression-free Survival (PFS) Reported With 80% Confidence Interval

From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. · Months

Platinum Response - Sensitive: Topotecan Monotherapy5.5 Months
Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy4.4 Months
Platinum Response - Resistant: Topotecan Monotherapy2.1 Months
Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy2.7 Months
Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy1.5 Months

Progression-free Survival (PFS) Reported With 95% Confidence Interval

From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. · Months

Platinum Response - Sensitive: Topotecan Monotherapy5.5 Months
Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy4.4 Months
Platinum Response - Resistant: Topotecan Monotherapy2.1 Months
Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy2.7 Months
Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy1.5 Months

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。