Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
Phase 2
Active, not recruiting
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05186974
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 193
Inclusion Criteria
- Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
- No prior systemic treatment for metastatic NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate hematologic counts
- Adequate hepatic function
Key
Exclusion Criteria
- Mixed SCLC and NSCLC histology
- Active second malignancy
- NSCLC that is eligible for definitive local therapy alone
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has had an allogenic tissue/solid organ transplant.
- Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
- Has received radiation therapy to the lung
- Individuals may not have received systemic anticancer treatment within the previous 6 months
- Is currently participating in or has participated in a study of an investigational agent
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Known active central nervous system (CNS) metastases
- History of cardiac disease
- Active chronic inflammatory bowel disease
- Active serious infection requiring antibiotics
- Active or chronic hepatitis B infection
- Positive hepatitis C antibody
- Positive serum pregnancy test or women who are lactating
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Carboplatin 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. SG + Pembrolizumab + Cisplatin (Cohort E) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab (Cohort B) 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. Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A) Sacituzumab Govitecan-hziy (SG) 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. Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A) Pembrolizumab 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. SG + Pembrolizumab (Cohort B) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin Safety Run-in Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin Safety Run-in 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. SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) Pembrolizumab 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. SG + Pembrolizumab + Carboplatin Safety Run-in Carboplatin 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. SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) Cisplatin 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Pembrolizumab 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Carboplatin 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Pembrolizumab 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. SG + Pembrolizumab + Cisplatin (Cohort E) Pembrolizumab 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) 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. SG + Pembrolizumab + Cisplatin (Cohort E) 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Up to 22 Months Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts First dose date up to 21 days
- Secondary Outcome Measures
Name Time Method Progression-free Survival as Assessed by IRC per RECIST Version 1.1 Up to 24 Months Overall Survival Up to 24 Months Duration of Response as Assessed by IRC per RECIST Version 1.1 Up to 24 Months Disease Control Rate as Assessed by IRC per RECIST Version 1.1 Up to 24 Months Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) First dose date up to 24 Months plus 30 days Percentage of Participants Experiencing Clinical Laboratory Abnormalities First dose date up to 24 Months plus 30 days
Trial Locations
- Locations (101)
Alaska Oncology and Hematology, LLC.
🇺🇸Anchorage, Alaska, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
🇺🇸Los Angeles, California, United States
UC Irvine Health
🇺🇸Orange, California, United States
Stanford Cancer Institute
🇺🇸Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
🇺🇸Aurora, Colorado, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Northside Hospital Central Research Department
🇺🇸Atlanta, Georgia, United States
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