Study Details

OVERVIEW

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 (EVOKE-02)

PROTOCOL 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).

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Non-small Cell Lung Cancer

Gender

N/A

Date

May 2022 - August 2024

Study Type

Interventional

Study Phase

Phase 2

Product

Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Carboplatin, Cisplatin

Eligibility Information

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

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.

Locations

Locations (101)

Alaska Oncology and Hematology, LLC.

Anchorage, Alaska, United States, 99508

Beverly Hills Cancer Center

Beverly Hills, California, United States, 90211

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California, United States, 90404

UC Irvine Health

Orange, California, United States, 92868

Stanford Cancer Institute

Stanford, California, United States, 94305

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Northside Hospital Central Research Department

Atlanta, Georgia, United States, 30342

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Rush University Medical Center

Chicago, Illinois, United States, 60612

Orchard Healthcare Research Inc.

Skokie, Illinois, United States, 60077

Kansas City Veterans Affairs Medical Center

Westwood, Kansas, United States, 66205

Kansas City VA Medical Center

Kansas City, Missouri, United States, 64128

Weill Cornell Medical/New York-Presbyterian Hospital

New York, New York, United States, 10065

Great Lakes Cancer Care

Williamsville, New York, United States, 14226

Wake Forest Baptist Health - High Point Medical Center

High Point, North Carolina, United States, 27262

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

University Hospital Cleveland Medical Center

Cleveland, Ohio, United States, 44106

OSU Brain & Spine Hospital

Columbus, Ohio, United States, 43220

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

North Sioux City, South Dakota, United States, 51101

Southern Highlands Cancer Centre

Bowral, New South Wales, Australia, 2576

Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

St George Private Hospital

Kogarah, New South Wales, Australia, 2217

Pindara Private Hospital

Benowa, Queensland, Australia, 4217

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia, 4575

Flinders Medical Centre

Bedford Park, South Australia, Australia, 5042

Ashford Cancer Centre Research

Windsor Gardens, South Australia, Australia, 5087

Peninsula Health - Frankston Hospital

Frankston, Victoria, Australia, 3199

Western Health - Sunshine Hospital

Melbourne, Victoria, Australia, 3021

Joondalup Health Campus

Joondalup, Western Australia, Australia, 6027

CIUSSS Saguenay Lac St-Jean

Quebec, Canada, G7H 5H6

McGill University Health Centre

Quebec, Canada, H4A 3J1

APHP - Hôpital Ambroise Paré

Boulogne-Billancourt, France, 92100

CHRU de Brest - Hopital Morvan

Brest, France, 29609

Centre Francois Baclesse

Caen, France, 14000

CHU de CAEN

Caen, France, 14000

Centre Jean Perrin - 58 rue Montalembert

Clermont-Ferrand, France, 63011

Centre Georges-François Leclerc

Dijon, France, 21000

Clinique Victor Hugo

Le Mans, France, 72000

Institut Curie

Paris, France, 75248

CHU de Bordeaux Hopital Haut leveque

Pessac, France, 33604

Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

Pierre Benite, France, 69495

Institut de Cancérologie de l'Ouest

Saint Herblain, France, 44805

Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH

Berlin, Germany, 13125

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 9116

Universitatsklinikum Koln, Klinik I fur Innere Medizin

Cologne, Germany, 50937

Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie

Esslingen, Germany, 73730

Universitatsklinikum Frankfurt

Frankfurt, Germany, 60590

Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie

Gauting, Germany, 82131

LungenClinic Grosshansdorf

Grosshansdorf, Germany, 22927

Martha-Maria Krankenhaus Halle Dölau gGmbH

Halle, Germany, 06120

LKI Lungenfachklinik Immenhausen

Immenhausen, Germany, 34376

Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong, 852

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, 25123

AOU Policlinico Vittorio Emanuele - POG Rodolico

Catania, Italy, 95125

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy, 43126

IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena

Rome, Italy, 00144

IRCCS Instituto Clinico Humanitas

Rozzano, Italy, 20089

Chungbuk National University Hospital

Cheongju-si, Korea, Republic of, 28644

Gachon University Gil Medical Center

Inchon, Korea, Republic of, 21565

Asan Medical Center

Seoul, Korea, Republic of, 05505

Seoul Metropolitan Government - Seoul National University Boramae Medical Center

Seoul, Korea, Republic of, 07061

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 120-752

The Catholic University of Korea St. Vincent's Hospital

Suwon, Korea, Republic of, 16247

Sultan Ismail Hospital

Johor Bahru, Malaysia, 81100

Hospital Raja Perempuan Zainab II

Kota Bharu, Malaysia, 15586

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 59100

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia, 25100

Sarawak General Hospital

Kuching, Malaysia, 93586

Institut Kanser Negara

Putrajaya, Malaysia, 62250

Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

A coruna, Spain, 15006

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Hospital Universitari Vall d'Hebrón

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital Duran i Reynals

Barcelona, Spain, 08908

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain, 28660

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain, 31008

Hospital Regional Universitario de Malaga-Hospital Civil

Rincon de la Victoria, Spain, 29011

Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario

Santiago de Compostela, Spain, 15706

Hospital Universitario Virgen de Valme

Sevilla, Spain, 41001

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Changhua Christian Hospital

Changhua City, Taiwan, 500-06

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

E-DA Hospital

Kaohsiung City, Taiwan, 824

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 83301

Chi Mei Hospital - Liouying

Liouying Dist., Taiwan

National Cheng Kung University Hospital

Tainan City, Taiwan

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei City, Taiwan, 110

National Taiwan University Hospital

Taipei City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan, 10002

Chang Gung Memorial Hospital (CGMH)

Taoyuan City, Taiwan, 33305

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B9 5SS

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 9RT

Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) (EVOKE-02)