STATUS Recruitment Complete

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (EVOKE-01)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-577-6153

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

May 07, 2026

Clinicaltrials.gov ID

NCT05089734

CTSID

2024-512148-50

STUDY DOCUMENTS

View study documents

OVERVIEW

Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (EVOKE-01)

PROTOCOL SUMMARY

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel 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

November 2021 - November 2023

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab Govitecan-hziy (SG), Docetaxel

Eligibility information

Inclusion criteria

Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.
Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.
No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.
Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm^3, and platelets ≥ 100,000/μL).
Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).
Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Exclusion criteria

Mixed small-cell lung cancer and NSCLC histology.
Positive serum pregnancy test or women who are lactating.
Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.
Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.
Previously received treatment with any of the following:
Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
Trop-2-targeted therapy
Docetaxel as monotherapy or in combination with other agents
Active second malignancy
NSCLC that is eligible for definitive local therapy alone.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Active cardiac disease
Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
Active serious infection requiring antibiotics.
Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.
Positive hepatitis C antibody and detectable hepatitis C viral load.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (227)

Alaska Oncology and Hematology, LLC.

Anchorage, Alaska, United States, 99508

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (EVOKE-01)

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 (227)

Alaska Oncology and Hematology, LLC.

USOR - Arizona Oncology Associates Tucson - Wilmot

Beverly Hills Cancer Center

Rocky Mountain Cancer Centers - Aurora

Florida Cancer Specialists (Administration and Drug Shipment)

Woodlands Medical Specialists, PA

Florida Cancer Specialists

Florida Cancer Specialists

University of Chicago Medical Center

Illinois Cancer Specialists

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

Kansas City VA Medical Center

Baptist Health Lexington

Maryland Oncology Hematology, P.A.

Lahey Hospital & Medical Center

Park Nicollet Frauenshuh Cancer Center

Nebraska Hematology - Oncology

Comprehensive Cancer Centers of Nevada

Broome Oncology, LLC

Stony Brook Cancer Center

Levine Cancer Institute

FirstHealth Outpatient Cancer Center

W.G (Bill) Hefner VAMC

Zangmeister Cancer Center

Tennessee Oncology, PLLC

Baptist Clinical Research Institute

Texas Oncology - Bedford

Texas Oncology - Denison

Texas Oncology - Denton South

Texas Oncology Cancer Care and Research Center

USOR - Texas Oncology - McKinney

Texas Oncology - Paris

Texas Oncology-Plano East

Texas Oncology-Plano West

Shenandoah Oncology Associates, PC

University of Wisconsin Clinical Science Center

Froedtert Hospital/Medical College of Wisconsin

Border Medical Oncology Research Unit

Southern Highlands Cancer Centre

St Vincent's Public Hospital

Sunshine Coast University Private Hospital

Gallipoli Medical Research Foundation

Flinders Medical centre

Icon Cancer Centre

Box Hill Hospital

Monash Health

Peninsula & South Eastern Haematology and Oncology Group

Joondalup Health Campus

ir Charles Gairdner Hospital

Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie

Muellner Hauptstrabe 48

zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU

Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie

Algemeen Ziekenhuis Klina

Cliniques Universitaires Saint-Luc

Universitair Ziekenhuis Antwerpen

Algemeen Ziekenhuis Sint-Lucas

Az Maria Middelares Ghent

CHU Ambroise Pare

CRIO - Centro Regional Integrado de Oncologia

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral

Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

Hospital de Clínicas de Porto Alegre - HCPA

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC

A Beneficência Portuguesa de São Paulo

Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP