Lung Cancer Clinical Trial
Study of Sacituzumab Govitecan-hziy Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations
Summary
The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.
Eligibility 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/Exclusion criteria may apply.
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There are 67 Locations for this study
Anchorage Alaska, 99508, United States
Beverly Hills California, 90211, United States
Los Angeles California, 90033, United States
Los Angeles California, 90404, United States
Orange California, 92868, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30342, United States
Skokie Illinois, 60077, United States
Kansas City Missouri, 64128, United States
Williamsville New York, 14226, United States
Pinehurst North Carolina, 28374, United States
Cleveland Ohio, 44106, United States
North Sioux City South Dakota, 51101, United States
Bowral New South Wales, 2576, Australia
Darlinghurst New South Wales, 2010, Australia
Benowa Queensland, 4217, Australia
Birtinya Queensland, 4575, Australia
Bedford Park South Australia, 5042, Australia
Windsor Gardens South Australia, 5087, Australia
Melbourne Victoria, 3021, Australia
Joondalup Western Australia, 6027, Australia
Quebec , H4A 3, Canada
Boulogne-Billancourt , 92100, France
Brest , 29609, France
Caen , 14000, France
Caen , 14000, France
Le Mans , 72000, France
Paris , 75248, France
Pessac , 33604, France
Pierre Benite , 69495, France
Saint Herblain , 44805, France
Cologne , 50937, Germany
Esslingen , 73730, Germany
Gauting , 82131, Germany
Grosshansdorf , 22927, Germany
Halle , 06120, Germany
Immenhausen , 34376, Germany
Hong Kong , 852, Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Kowloon , , Hong Kong
Brescia , 25123, Italy
Catania , 95125, Italy
Cheongjusi , 28644, Korea, Republic of
Inchon , 21565, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 07061, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Suwon , 16247, Korea, Republic of
A coruna , 15006, Spain
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08908, Spain
Madrid , 28007, Spain
Majadahonda , 28660, Spain
Pamplona , 31008, Spain
Rincon de la Victoria , 29011, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41001, Spain
Sevilla , 41009, Spain
Valencia , 46026, Spain
Changhua City , 500-0, Taiwan
Kaohsiung City , 80756, Taiwan
Kaohsiung City , 824, Taiwan
Kaohsiung , 83301, Taiwan
Liouying Dist. , , Taiwan
Tainan City , , Taiwan
Taipei City , 110, Taiwan
Taipei City , , Taiwan
Taipei , 10002, Taiwan
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