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Non-small Cell Lung CancerPhase 2EVOKE-02NCT05186974

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

A Phase 2 study testing Sacituzumab Govitecan-hziy (SG), Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by Gilead Sciences at 101 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Sacituzumab Govitecan-hziy (SG), Pembrolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
101 sitesin 12 countries
Study dates
30 May 2022to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

101 sites in 12 countries.

101 sites in 12 countries

United States22 sites

  • Alaska Oncology and Hematology, LLC.

    Anchorage, Alaska, 99508

  • Northside Hospital Central Research Department

    Atlanta, Georgia, 30342

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106

  • OSU Brain & Spine Hospital

    Columbus, Ohio, 43220

  • Wake Forest Baptist Health - High Point Medical Center

    High Point, North Carolina, 27262

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA Hematology/Oncology - Santa Monica

    Los Angeles, California, 90404

  • Weill Cornell Medical/New York-Presbyterian Hospital

    New York, New York, 10065

  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

    North Sioux City, South Dakota, 51101

  • UC Irvine Health

    Orange, California, 92868

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Stanford Cancer Institute

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Kansas City Veterans Affairs Medical Center

    Westwood, Kansas, 66205

  • Great Lakes Cancer Care

    Williamsville, New York, 14226

Other trials in United States

Spain13 sites

  • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

    A Coruña, 15006

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28660

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008

  • Hospital Regional Universitario de Malaga-Hospital Civil

    Rincón de la Victoria, 29011

  • Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen de Valme

    Seville, 41001

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France11 sites

  • APHP - Hôpital Ambroise Paré

    Boulogne-Billancourt, 92100

  • CHRU de Brest - Hopital Morvan

    Brest, 29609

  • Centre Francois Baclesse

    Caen, 14000

  • CHU de CAEN

    Caen, 14000

  • Centre Jean Perrin - 58 rue Montalembert

    Clermont-Ferrand, 63011

  • Centre Georges-François Leclerc

    Dijon, 21000

  • Clinique Victor Hugo

    Le Mans, 72000

  • Institut Curie

    Paris, 75248

  • CHU de Bordeaux Hopital Haut leveque

    Pessac, 33604

  • Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

Other trials in France

Australia10 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

  • Southern Highlands Cancer Centre

    Bowral, New South Wales, 2576

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Peninsula Health - Frankston Hospital

    Frankston, Victoria, 3199

  • Joondalup Health Campus

    Joondalup, Western Australia, 6027

  • St George Private Hospital

    Kogarah, New South Wales, 2217

  • Western Health - Sunshine Hospital

    Melbourne, Victoria, 3021

  • Ashford Cancer Centre Research

    Windsor Gardens, South Australia, 5087

Other trials in Australia

Taiwan10 sites

  • Changhua Christian Hospital

    Changhua, 500-06

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • E-DA Hospital

    Kaohsiung City, 824

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chi Mei Hospital - Liouying

    Liouying Dist.

  • National Cheng Kung University Hospital

    Tainan

  • Taipei Veterans General Hospital

    Taipei, 10002

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Taipei, 110

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Memorial Hospital (CGMH)

    Taoyuan City, 33305

Other trials in Taiwan

Germany9 sites

  • Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH

    Berlin, 13125

  • Klinikum Chemnitz gGmbH

    Chemnitz, 9116

  • Universitatsklinikum Koln, Klinik I fur Innere Medizin

    Cologne, 50937

  • Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie

    Esslingen am Neckar, 73730

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie

    Gauting, 82131

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927

  • Martha-Maria Krankenhaus Halle Dölau gGmbH

    Halle, 06120

  • LKI Lungenfachklinik Immenhausen

    Immenhausen, 34376

Other trials in Germany

Malaysia7 sites

  • Sultan Ismail Hospital

    Johor Bahru, 81100

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, 15586

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Sarawak General Hospital

    Kuching, 93586

  • Institut Kanser Negara

    Putrajaya, 62250

Other trials in Malaysia

South Korea6 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Gachon University Gil Medical Center

    Inchon, 21565

  • Asan Medical Center

    Seoul, 05505

  • Seoul Metropolitan Government - Seoul National University Boramae Medical Center

    Seoul, 07061

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

Italy5 sites

  • ASST Spedali Civili di Brescia

    Brescia, 25123

  • AOU Policlinico Vittorio Emanuele - POG Rodolico

    Catania, 95125

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

  • IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena

    Rome, 00144

  • IRCCS Instituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Hong Kong4 sites

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

    Hong Kong, 852

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Hong Kong United Oncology Center

    Kowloon

Other trials in Hong Kong

Canada2 sites

  • CIUSSS Saguenay Lac St-Jean

    Québec, G7H 5H6

  • McGill University Health Centre

    Québec, H4A 3J1

Other trials in Canada

United Kingdom2 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

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

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).

Being tested
Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Carboplatin, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziy (SG)Drug

    Also called GS-0132, IMMU-132

    Administered intravenously

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Administered intravenously

  • CarboplatinDrug

    Also called Paraplatin®

    Administered intravenously

  • CisplatinDrug

    Also called Platinol®

    Administered intravenously

Study groups in NCT05186974
Study groupRoleWhat they receive
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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab
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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab
SG + Pembrolizumab + Carboplatin Safety Run-inExperimentalParticipants 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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab; Drug: Carboplatin
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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab; Drug: Cisplatin
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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin
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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin
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.
Receives: Drug: Sacituzumab Govitecan-hziy (SG); Drug: Pembrolizumab; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Up to 22 Months

  2. Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts

    Measured: First dose date up to 21 days

Secondary outcomes (6)

  1. Progression-free Survival as Assessed by IRC per RECIST Version 1.1

    Measured: Up to 24 Months

  2. Overall Survival

    Measured: Up to 24 Months

  3. Duration of Response as Assessed by IRC per RECIST Version 1.1

    Measured: Up to 24 Months

  4. Disease Control Rate as Assessed by IRC per RECIST Version 1.1

    Measured: Up to 24 Months

  5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: First dose date up to 24 Months plus 30 days

  6. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Measured: First dose date up to 24 Months plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start30 May 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186974
Sponsor's protocol ID
GS-US-576-6220
Other IDs
2021-004280-27, KEYNOTE-D15, MK-3475-D15, 2024-513225-23
Acronym
EVOKE-02
Status last verified
Sep 2026
First submitted
23 Dec 2021
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reck M, Patel JD, Gray JE, Reguart N, Cobo M, Pradera JF, Felip E, Cappuzzo F, Garon EB, Neal JW, Mekan S, Safavi F, Fernando N, Zavodovskaya M, Jurgensmeier JM, Chisamore M, Cho BC. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study. J Thorac Oncol. 2026 Mar;21(3):103509. doi: 10.1016/j.jtho.2025.10.016. Epub 2025 Oct 30.

    PubMed 41173143

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan-hziy (SG), Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by Gilead Sciences at 101 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Spain, France, Australia, Taiwan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Up to 22 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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