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
Sites (78)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Pindara Private Hospital Coordinator of this site? Confirm its status | Benowa | Australia | Unknown status |
| Sunshine Coast University Private Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Unknown status |
| Southern Highlands Cancer Centre Coordinator of this site? Confirm its status | Bowral | Australia | Unknown status |
| Saint Vincents Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Peninsula Health - Frankston Hospital Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Joondalup Health Campus Coordinator of this site? Confirm its status | Joondalup | Australia | Unknown status |
| St George Private Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Western Health - Sunshine Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Ashford Cancer Centre Research Coordinator of this site? Confirm its status | Windsor Gardens | Australia | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| CIUSSS Saguenay Lac St-Jean Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Asklepios Klinik Gauting GmbH Coordinator of this site? Confirm its status | Gauting | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Completed |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| Hong Kong United Oncology Center Coordinator of this site? Confirm its status | Kowloon | Hong Kong | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Inchon | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Sultan Ismail Hospital Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Hospital Raja Perempuan Zainab II Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Tengku Ampuan Afzan Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| Sarawak General Hospital Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Institut Kanser Negara Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chi Mei Hospital - Liouying Coordinator of this site? Confirm its status | Liouying Dist. | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital (CGMH) Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Alaska Oncology and Hematology LLC Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Northside Hospital Central Research Department Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Beverly Hills Cancer Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospital Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| OSU Brain & Spine Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Wake Forest Baptist Health - High Point Medical Center Coordinator of this site? Confirm its status | High Point | United States | Unknown status |
| Kansas City VA Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| UCLA Hematology/Oncology - Santa Monica Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Weill Cornell Medical/New York-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Coordinator of this site? Confirm its status | North Sioux City | United States | Unknown status |
| UC Irvine Health Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| FirstHealth Outpatient Cancer Center Coordinator of this site? Confirm its status | Pinehurst | United States | Unknown status |
| Orchard Healthcare Research Inc. Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Kansas City Veterans Affairs Medical Center Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Great Lakes Cancer Care Coordinator of this site? Confirm its status | Williamsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.