Non-small Cell Lung Cancer
Conditions
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).
Interventions
Administered intravenously
DRUGPembrolizumab
Administered intravenously
DRUGCarboplatin
Administered intravenously
DRUGCisplatin
Administered intravenously
Sponsors
Gilead Sciences
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, Canada, France, Germany, Hong Kong, Italy, Malaysia, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed