A Phase 2 interventional study of Sacituzumab Govitecan-hziy (SG) and Pembrolizumab in Non-small Cell Lung Cancer, sponsored by Gilead Sciences. Active, not recruiting at 101 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 193 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab
Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab
Participants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg 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.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab · Drug: Carboplatin
Participants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m\^2 on Day 1 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab · Drug: Cisplatin
Participants assigned to Cohort C 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 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab · Drug: Carboplatin · Drug: Cisplatin
Participants assigned to Cohort D 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 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab · Drug: Carboplatin · Drug: Cisplatin
Participants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m\^2 on Day 1 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy (SG) · Drug: Pembrolizumab · Drug: Cisplatin
Administered intravenously
Also known as: GS-0132, IMMU-132
Administered intravenously
Also known as: KEYTRUDA®
Administered intravenously
Also known as: Paraplatin®
Administered intravenously
Also known as: Platinol®
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 22 Months
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Time frame: First dose date up to 21 days
Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Time frame: Up to 24 Months
Overall Survival
Time frame: Up to 24 Months
Duration of Response as Assessed by IRC per RECIST Version 1.1
Time frame: Up to 24 Months
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Time frame: Up to 24 Months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 24 Months plus 30 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 24 Months plus 30 days
Showing the first 100 of 101 sites across 12 countries.
Plan to share: No
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Gilead Sciences