EVOKE-02: This phase II study is seeking to determine the appropriate dose level, safety and effectiveness of targeted therapy (Sacituzumab Govitecan-hziy) in combination with immunotherapy (pembrolizumab) or in combination with immunotherapy and chemotherapy (pembrolizumab, carboplatin and/or cisplatin) in people with advanced or metastatic non-small cell lung cancerAn 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

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.