Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
EVOKE-02
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
5 other identifiers
interventional
193
12 countries
101
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started May 2022
Typical duration for phase_2 nonsmall-cell-lung-cancer
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedStudy Start
First participant enrolled
May 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 11, 2026
February 1, 2026
4.3 years
December 23, 2021
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Up to 22 Months
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
First dose date up to 21 days
Secondary Outcomes (6)
Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Up to 24 Months
Overall Survival
Up to 24 Months
Duration of Response as Assessed by IRC per RECIST Version 1.1
Up to 24 Months
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Up to 24 Months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
First dose date up to 24 Months plus 30 days
- +1 more secondary outcomes
Study Arms (7)
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
EXPERIMENTALParticipants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
SG + Pembrolizumab (Cohort B)
EXPERIMENTALParticipants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
SG + Pembrolizumab + Carboplatin Safety Run-in
EXPERIMENTALParticipants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle.
SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
EXPERIMENTALParticipants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m\^2 on Day 1 of a 21-day cycle.
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
EXPERIMENTALParticipants assigned to Cohort C according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
EXPERIMENTALParticipants assigned to Cohort D according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
SG + Pembrolizumab + Cisplatin (Cohort E)
EXPERIMENTALParticipants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m\^2 on Day 1 of a 21-day cycle.
Interventions
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (101)
Alaska Oncology and Hematology, LLC.
Anchorage, Alaska, 99508, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404, United States
UC Irvine Health
Orange, California, 92868, United States
Stanford Cancer Institute
Stanford, California, 94305, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northside Hospital Central Research Department
Atlanta, Georgia, 30342, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077, United States
Kansas City Veterans Affairs Medical Center
Westwood, Kansas, 66205, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Weill Cornell Medical/New York-Presbyterian Hospital
New York, New York, 10065, United States
Great Lakes Cancer Care
Williamsville, New York, 14226, United States
Wake Forest Baptist Health - High Point Medical Center
High Point, North Carolina, 27262, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106, United States
OSU Brain & Spine Hospital
Columbus, Ohio, 43220, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
North Sioux City, South Dakota, 51101, United States
Southern Highlands Cancer Centre
Bowral, New South Wales, 2576, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
St George Private Hospital
Kogarah, New South Wales, 2217, Australia
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Ashford Cancer Centre Research
Windsor Gardens, South Australia, 5087, Australia
Peninsula Health - Frankston Hospital
Frankston, Victoria, 3199, Australia
Western Health - Sunshine Hospital
Melbourne, Victoria, 3021, Australia
Joondalup Health Campus
Joondalup, Western Australia, 6027, Australia
CIUSSS Saguenay Lac St-Jean
Québec, G7H 5H6, Canada
McGill University Health Centre
Québec, H4A 3J1, Canada
APHP - Hôpital Ambroise Paré
Boulogne-Billancourt, 92100, France
CHRU de Brest - Hopital Morvan
Brest, 29609, France
Centre Francois Baclesse
Caen, 14000, France
CHU de CAEN
Caen, 14000, France
Centre Jean Perrin - 58 rue Montalembert
Clermont-Ferrand, 63011, France
Centre Georges-François Leclerc
Dijon, 21000, France
Clinique Victor Hugo
Le Mans, 72000, France
Institut Curie
Paris, 75248, France
CHU de Bordeaux Hopital Haut leveque
Pessac, 33604, France
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH
Berlin, 13125, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 9116, Germany
Universitatsklinikum Koln, Klinik I fur Innere Medizin
Cologne, 50937, Germany
Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, 73730, Germany
Universitatsklinikum Frankfurt
Frankfurt, 60590, Germany
Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie
Gauting, 82131, Germany
LungenClinic Grosshansdorf
Großhansdorf, 22927, Germany
Martha-Maria Krankenhaus Halle Dölau gGmbH
Halle, 06120, Germany
LKI Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, 852, Hong Kong
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, 25123, Italy
AOU Policlinico Vittorio Emanuele - POG Rodolico
Catania, 95125, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126, Italy
IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena
Rome, 00144, Italy
IRCCS Instituto Clinico Humanitas
Rozzano, 20089, Italy
Sultan Ismail Hospital
Johor Bahru, 81100, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, 15586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Institut Kanser Negara
Putrajaya, 62250, Malaysia
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Gachon University Gil Medical Center
Inchon, 21565, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, 16247, South Korea
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruña, 15006, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28660, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008, Spain
Hospital Regional Universitario de Malaga-Hospital Civil
Rincón de la Victoria, 29011, Spain
Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen de Valme
Seville, 41001, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Changhua Christian Hospital
Changhua, 500-06, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
E-DA Hospital
Kaohsiung City, 824, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Chi Mei Hospital - Liouying
Liouying Dist., Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, 10002, Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, 110, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital (CGMH)
Taoyuan, 33305, Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B9 5SS, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2021
First Posted
January 11, 2022
Study Start
May 30, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share