Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
Phase 2
Active, not recruiting
NCT03896503
| Condition | Extensive Stage Lung Small Cell Carcinoma, Extrapulmonary Small Cell Neuroendocrine Carcinoma, Limited Stage Lung Small Cell Carcinoma, Platinum-Resistant Lung Small Cell Carcinoma |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 104 participants |
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| Interventions | Berzosertib, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Topotecan Hydrochloride |
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| Start date | Dec 30, 2019 |
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| Completion date | Dec 19, 2022 |
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| Results posted | Nov 13, 2024 |
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Summary
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 Monotherapy | 5.5 Months |
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| Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 4.4 Months |
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| Platinum Response - Resistant: Topotecan Monotherapy | 2.1 Months |
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| Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 2.7 Months |
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| Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 1.5 Months |
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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 Monotherapy | 5.5 Months |
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| Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 4.4 Months |
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| Platinum Response - Resistant: Topotecan Monotherapy | 2.1 Months |
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| Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 2.7 Months |
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| Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 1.5 Months |
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Open in BENITIONS
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