Clinical trial NCT05186974: Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-01-11
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: Up to 22 Months
measure: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
timeFrame: First dose date up to 21 days
Secondary outcomes:
measure: Progression-free Survival as Assessed by IRC per RECIST Version 1.1
timeFrame: Up to 24 Months
measure: Overall Survival
timeFrame: Up to 24 Months
measure: Duration of Response as Assessed by IRC per RECIST Version 1.1
timeFrame: Up to 24 Months
measure: Disease Control Rate as Assessed by IRC per RECIST Version 1.1
timeFrame: Up to 24 Months
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 24 Months plus 30 days
measure: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
timeFrame: First dose date up to 24 Months plus 30 days
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology, LLC.
state: Alaska
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital Central Research Department
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Westwood
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical/New York-Presbyterian Hospital
state: New York
city: Williamsville
country: United States
facility: Great Lakes Cancer Care
state: New York
city: High Point
country: United States
facility: Wake Forest Baptist Health - High Point Medical Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: OSU Brain & Spine Hospital
state: Ohio
city: North Sioux City
country: United States
facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
state: South Dakota
city: Bowral
country: Australia
facility: Southern Highlands Cancer Centre
state: New South Wales
city: Darlinghurst
country: Australia
facility: Saint Vincents Hospital Sydney
state: New South Wales
city: Kogarah
country: Australia
facility: St George Private Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Birtinya
country: Australia
facility: Sunshine Coast University Private Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Windsor Gardens
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Frankston
country: Australia
facility: Peninsula Health - Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Western Health - Sunshine Hospital
state: Victoria
city: Joondalup
country: Australia
facility: Joondalup Health Campus
state: Western Australia
city: Quebec
country: Canada
facility: CIUSSS Saguenay Lac St-Jean
city: Quebec
country: Canada
facility: McGill University Health Centre
city: Boulogne-Billancourt
country: France
facility: APHP - Hôpital Ambroise Paré
city: Brest
country: France
facility: CHRU de Brest - Hopital Morvan
city: Caen
country: France
facility: Centre Francois Baclesse
city: Caen
country: France
facility: CHU de CAEN
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - 58 rue Montalembert
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Paris
country: France
facility: Institut Curie
city: Pessac
country: France
facility: CHU de Bordeaux Hopital Haut leveque
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Cologne
country: Germany
facility: Universitatsklinikum Koln, Klinik I fur Innere Medizin
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Halle
country: Germany
facility: Martha-Maria Krankenhaus Halle Dölau gGmbH
city: Immenhausen
country: Germany
facility: LKI Lungenfachklinik Immenhausen
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Center
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele - POG Rodolico
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Rome
country: Italy
facility: IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena
city: Rozzano
country: Italy
facility: IRCCS Instituto Clinico Humanitas
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Inchon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government - Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Johor Bahru
country: Malaysia
facility: Sultan Ismail Hospital
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
city: A coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: Rincon de la Victoria
country: Spain
facility: Hospital Regional Universitario de Malaga-Hospital Civil
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung City
country: Taiwan
facility: E-DA Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Liouying Dist.
country: Taiwan
facility: Chi Mei Hospital - Liouying
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital (CGMH)
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: