Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
NCT ID: NCT05186974
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
193 participants
INTERVENTIONAL
2022-05-30
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
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)
Administered intravenously
Pembrolizumab
Administered intravenously
SG + Pembrolizumab (Cohort B)
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)
Administered intravenously
Pembrolizumab
Administered intravenously
SG + Pembrolizumab + Carboplatin Safety Run-in
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.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Carboplatin
Administered intravenously
SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
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.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Cisplatin
Administered intravenously
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
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.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Carboplatin
Administered intravenously
Cisplatin
Administered intravenously
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
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.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Carboplatin
Administered intravenously
Cisplatin
Administered intravenously
SG + Pembrolizumab + Cisplatin (Cohort E)
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.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Cisplatin
Administered intravenously
Interventions
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Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Pembrolizumab
Administered intravenously
Carboplatin
Administered intravenously
Cisplatin
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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 D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital Central Research Department
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Kansas City Veterans Affairs Medical Center
Westwood, Kansas, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Weill Cornell Medical/New York-Presbyterian Hospital
New York, New York, United States
Great Lakes Cancer Care
Williamsville, New York, United States
Wake Forest Baptist Health - High Point Medical Center
High Point, North Carolina, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States
OSU Brain & Spine Hospital
Columbus, Ohio, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
North Sioux City, South Dakota, United States
Southern Highlands Cancer Centre
Bowral, New South Wales, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
St George Private Hospital
Kogarah, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Ashford Cancer Centre Research
Windsor Gardens, South Australia, Australia
Peninsula Health - Frankston Hospital
Frankston, Victoria, Australia
Western Health - Sunshine Hospital
Melbourne, Victoria, Australia
Joondalup Health Campus
Joondalup, Western Australia, Australia
CIUSSS Saguenay Lac St-Jean
Québec, , Canada
McGill University Health Centre
Québec, , Canada
APHP - Hôpital Ambroise Paré
Boulogne-Billancourt, , France
CHRU de Brest - Hopital Morvan
Brest, , France
Centre Francois Baclesse
Caen, , France
CHU de CAEN
Caen, , France
Centre Jean Perrin - 58 rue Montalembert
Clermont-Ferrand, , France
Centre Georges-François Leclerc
Dijon, , France
Clinique Victor Hugo
Le Mans, , France
Institut Curie
Paris, , France
CHU de Bordeaux Hopital Haut leveque
Pessac, , France
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitatsklinikum Koln, Klinik I fur Innere Medizin
Cologne, , Germany
Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie
Gauting, , Germany
LungenClinic Grosshansdorf
Großhansdorf, , Germany
Martha-Maria Krankenhaus Halle Dölau gGmbH
Halle, , Germany
LKI Lungenfachklinik Immenhausen
Immenhausen, , Germany
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Elizabeth Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Hong Kong United Oncology Center
Kowloon, , Hong Kong
ASST Spedali Civili di Brescia
Brescia, , Italy
AOU Policlinico Vittorio Emanuele - POG Rodolico
Catania, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena
Rome, , Italy
IRCCS Instituto Clinico Humanitas
Rozzano, , Italy
Sultan Ismail Hospital
Johor Bahru, , Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Institut Kanser Negara
Putrajaya, , Malaysia
Chungbuk National University Hospital
Cheongju-si, , South Korea
Gachon University Gil Medical Center
Inchon, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruña, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Duran i Reynals
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, , Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, , Spain
Hospital Regional Universitario de Malaga-Hospital Civil
Rincón de la Victoria, , Spain
Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario
Santiago de Compostela, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
E-DA Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chi Mei Hospital - Liouying
Liouying Dist., , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital (CGMH)
Taoyuan, , Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2021-004280-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-D15
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-D15
Identifier Type: OTHER
Identifier Source: secondary_id
2024-513225-23
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-576-6220
Identifier Type: -
Identifier Source: org_study_id
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