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NCT05186974Active, not recruitingPhase 2

Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
193 (actual)
First submitted
23 Dec 2021
Start date
30 May 2022
Primary completion date
Mar 2027
Lead sponsor
Gilead Sciences
Diseases
Lung cancer
NCT number
NCT05186974
EU CT number
2024-513225-23-00
EudraCT number
2021-004280-27

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 193
  • From 30 May 2022 to the primary completion date, Mar 2027
  • 78 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • NSCLC that is eligible for definitive local therapy alone
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has had an allogenic tissue/solid organ transplant.
  • 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

Other illness

  • Active second malignancy
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • History of cardiac disease
  • Active chronic inflammatory bowel disease
  • Active serious infection requiring antibiotics
  • Active or chronic hepatitis B infection
  • Positive hepatitis C antibody

Lab values

  • Positive serum pregnancy test or women who are lactating
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Mixed SCLC and NSCLC histology
  • Known active central nervous system (CNS) metastases

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (78)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Pindara Private Hospital
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BenowaAustraliaUnknown status
Sunshine Coast University Private Hospital
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BirtinyaAustraliaUnknown status
Southern Highlands Cancer Centre
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BowralAustraliaUnknown status
Saint Vincents Hospital Sydney
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DarlinghurstAustraliaUnknown status
Peninsula Health - Frankston Hospital
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FrankstonAustraliaUnknown status
Joondalup Health Campus
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JoondalupAustraliaUnknown status
St George Private Hospital
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KogarahAustraliaUnknown status
Western Health - Sunshine Hospital
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MelbourneAustraliaUnknown status
Ashford Cancer Centre Research
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Windsor GardensAustraliaUnknown status
McGill University Health Centre
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QuébecCanadaUnknown status
CIUSSS Saguenay Lac St-Jean
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QuébecCanadaUnknown status
Goethe University Frankfurt
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Frankfurt Am MainGermanyCompleted
Asklepios Klinik Gauting GmbH
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GautingGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Institut Curie
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ParisFranceCompleted
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
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Hong KongHong KongUnknown status
Queen Mary Hospital
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Hong KongHong KongUnknown status
Queen Elizabeth Hospital
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Hong KongHong KongUnknown status
Hong Kong United Oncology Center
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KowloonHong KongUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyCompleted
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Gachon University Gil Medical Center
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InchonSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul Metropolitan Government Seoul National University Boramae Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
Sultan Ismail Hospital
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Johor BahruMalaysiaUnknown status
Hospital Raja Perempuan Zainab II
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Kota BharuMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
Hospital Tengku Ampuan Afzan
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KuantanMalaysiaUnknown status
Sarawak General Hospital
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KuchingMalaysiaUnknown status
Institut Kanser Negara
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PutrajayaMalaysiaUnknown status
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
E-DA Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Chi Mei Hospital - Liouying
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Liouying Dist.TaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital (CGMH)
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Taoyuan CityTaiwanUnknown status
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesUnknown status
Northside Hospital Central Research Department
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AtlantaUnited StatesUnknown status
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
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AuroraUnited StatesUnknown status
Beverly Hills Cancer Center
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Beverly HillsUnited StatesUnknown status
Rush University Medical Center
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ChicagoUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
University Hospital Cleveland Medical Center
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ClevelandUnited StatesUnknown status
OSU Brain & Spine Hospital
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ColumbusUnited StatesUnknown status
Wake Forest Baptist Health - High Point Medical Center
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High PointUnited StatesUnknown status
Kansas City VA Medical Center
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Kansas CityUnited StatesUnknown status
UCLA Hematology/Oncology - Santa Monica
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Los AngelesUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Weill Cornell Medical/New York-Presbyterian Hospital
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New YorkUnited StatesUnknown status
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
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North Sioux CityUnited StatesUnknown status
UC Irvine Health
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OrangeUnited StatesUnknown status
FirstHealth Outpatient Cancer Center
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PinehurstUnited StatesUnknown status
Orchard Healthcare Research Inc.
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SkokieUnited StatesUnknown status
Stanford Cancer Institute
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StanfordUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Georgetown University Medical Center
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Washington D.C.United StatesUnknown status
Kansas City Veterans Affairs Medical Center
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WestwoodUnited StatesUnknown status
Great Lakes Cancer Care
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WilliamsvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.