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

Study details

Medical Condition

Non-small Cell Lung Cancer

Gender

N/A

Date

May 2022 - September 2026

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

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

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (101)

Alaska Oncology and Hematology, LLC.

Beverly Hills Cancer Center

USC/Norris Comprehensive Cancer Center

UCLA Hematology/Oncology - Santa Monica

UC Irvine Health

Stanford Cancer Institute

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Georgetown University Medical Center

Moffitt Cancer Center

Northside Hospital Central Research Department

Northwestern Memorial Hospital

Rush University Medical Center

Orchard Healthcare Research Inc.

Kansas City Veterans Affairs Medical Center

Kansas City VA Medical Center

Weill Cornell Medical/New York-Presbyterian Hospital

Great Lakes Cancer Care

Wake Forest Baptist Health - High Point Medical Center

FirstHealth Outpatient Cancer Center

University Hospital Cleveland Medical Center

OSU Brain & Spine Hospital

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

Southern Highlands Cancer Centre

Saint Vincents Hospital Sydney

St George Private Hospital

Pindara Private Hospital

Sunshine Coast University Private Hospital

Flinders Medical Centre

Ashford Cancer Centre Research

Peninsula Health - Frankston Hospital

Western Health - Sunshine Hospital

Joondalup Health Campus

CIUSSS Saguenay Lac St-Jean

McGill University Health Centre

APHP - Hôpital Ambroise Paré

CHRU de Brest - Hopital Morvan

Centre Francois Baclesse

CHU de CAEN

Centre Jean Perrin - 58 rue Montalembert

Centre Georges-François Leclerc

Clinique Victor Hugo

Institut Curie

CHU de Bordeaux Hopital Haut leveque

Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

Institut de Cancérologie de l'Ouest

Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH

Klinikum Chemnitz gGmbH

Universitatsklinikum Koln, Klinik I fur Innere Medizin

Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie

Universitatsklinikum Frankfurt

Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie

LungenClinic Grosshansdorf

Martha-Maria Krankenhaus Halle Dölau gGmbH

LKI Lungenfachklinik Immenhausen

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

Queen Elizabeth Hospital

Queen Mary Hospital

Hong Kong United Oncology Center

ASST Spedali Civili di Brescia

AOU Policlinico Vittorio Emanuele - POG Rodolico

Azienda Ospedaliero-Universitaria di Parma

IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena

IRCCS Instituto Clinico Humanitas

Sultan Ismail Hospital

Hospital Raja Perempuan Zainab II

Hospital Kuala Lumpur

University Malaya Medical Centre

Hospital Tengku Ampuan Afzan