Clinical summary
Summary
This study consists of 6 experimental cohorts, 2 of which are safety-run in cohorts. In the Safety Run in Cohort for Sacituzumab Govitecan-hziy (SG) + pembrolizumab + carboplatin, participants will receive SG (de-escalating dose levels: 10.0mg/kg, 7.5mg/kg, or 5.0mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle. In the Safety Run in Cohort for SG + pembrolizumab + cisplatin, participants will receive SG (either 10mg/kg or 7.5mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + cisplatin (75mg/m^2) on Day 1 of a 21-day cycle. In the Experimental Cohort A, participants assigned to Cohort A according to tumour proportion score (TPS) status will receive SG (10mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle. In the Experimental Cohort B according to TPS status will receive SG (10mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle. In Experimental Cohort C, participants assigned according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin (75mg/m^2) as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. In Experimental Cohort D, participants assigned according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin (75mg/m^2) as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. All treatments will be administered intravenously.Conditions
This trial is treating patients with non-small cell lung cancer.
Cancer
Lung cancer
Age
18+
More information
Trial Identifiers
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Commercial Sponsor
Gilead Sciences, Inc.
Scientific Title
An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations