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

Phase 2 Active, not recruiting NCT03896503

ConditionExtensive Stage Lung Small Cell Carcinoma, Extrapulmonary Small Cell Neuroendocrine Carcinoma, Limited Stage Lung Small Cell Carcinoma, Platinum-Resistant Lung Small Cell Carcinoma
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment104 participants
InterventionsBerzosertib, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Topotecan Hydrochloride
Start dateDec 30, 2019
Completion dateDec 19, 2022
Results postedNov 13, 2024

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 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

Open in BENITIONS View on ClinicalTrials.gov

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