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

March 29, 2024 updated by: Gilead Sciences

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Bowral, New South Wales, Australia, 2576
        • Southern Highlands Cancer Centre
      • Darlinghurst, New South Wales, Australia, 2010
        • Saint Vincents Hospital Sydney
      • Kogarah, New South Wales, Australia, 2217
        • St George private Hospital
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • Pindara Private Hospital
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Private Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Windsor Gardens, South Australia, Australia, 5087
        • Ashford Cancer Centre Research
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Health - Frankston Hospital
      • Melbourne, Victoria, Australia, 3021
        • Western Health - Sunshine Hospital
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
        • Joondalup Health campus
  • Canada
      • Quebec, Canada, G7H 5H6
        • CIUSSS Saguenay Lac St-Jean
      • Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • France
      • Boulogne-Billancourt, France, 92100
        • APHP - Hôpital Ambroise Paré
      • Brest, France, 29609
        • CHRU de Brest - Hôpital Morvan
      • Caen, France, 14000
        • Centre Francois Baclesse
      • Caen, France, 14000
        • CHU de Caen
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin - 58 rue Montalembert
      • Dijon, France, 21000
        • Centre Georges-François Leclerc
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Paris, France, 75248
        • Institut Curie
      • Pessac, France, 33604
        • CHU de Bordeaux Hopital Haut leveque
      • Pierre Benite, France, 69495
        • Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
      • Saint Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest
  • Germany
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH
      • Chemnitz, Germany, 9116
        • Klinikum Chemnitz gGmbH
      • Cologne, Germany, 50937
        • Universitatsklinikum Koln, Klinik I fur Innere Medizin
      • Esslingen, Germany, 73730
        • Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie
      • Grosshansdorf, Germany, 22927
        • LungenClinic Grosshansdorf
      • Halle, Germany, 06120
        • Martha-Maria Krankenhaus Halle Dölau gGmbH
      • Immenhausen, Germany, 34376
        • Lki Lungenfachklinik Immenhausen
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital
      • Hong Kong, Hong Kong, 852
        • Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
      • Kowloon, Hong Kong
        • Hong Kong United Oncology Center
  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali Civili di Brescia
      • Catania, Italy, 95125
        • AOU Policlinico Vittorio Emanuele - POG Rodolico
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma
      • Rome, Italy, 00144
        • IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena
      • Rozzano, Italy, 20089
        • IRCCS Instituto Clinico Humanitas
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Inchon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government - Seoul National University Boramae Medical Center
      • Suwon, Korea, Republic of, 16247
        • The Catholic University Of Korea St. Vincent's Hospital
  • Malaysia
      • Johor Bahru, Malaysia, 81100
        • Sultan Ismail Hospital
      • Kota Bharu, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuantan, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
      • Kuching, Malaysia, 93586
        • Sarawak General Hospital
      • Putrajaya, Malaysia, 62250
        • Institut Kanser Negara
  • Spain
      • A coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall D'Hebron
      • Barcelona, Spain, 08908
        • Hospital Duran I Reynals
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Majadahonda, Spain, 28660
        • Hospital Universitario Puerta de Hierro de Majadahonda
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
      • Rincon de la Victoria, Spain, 29011
        • Hospital Regional Universitario de Malaga-Hospital Civil
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41001
        • Hospital Universitario Virgen de Valme
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
  • Taiwan
      • Changhua City, Taiwan, 500-06
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 824
        • E-DA Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Liouying Dist., Taiwan
        • Chi Mei Hospital - Liouying
      • Tainan City, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • Taipei Veterans General Hospital
      • Taipei City, Taiwan
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 110
        • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Memorial Hospital (CGMH)
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology, LLC.
    • California
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90404
        • UCLA Hematology/Oncology - Santa Monica
      • Orange, California, United States, 92868
        • UC Irvine Health
      • Stanford, California, United States, 94305
        • Stanford Cancer Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital Central Research Department
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research Inc.
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Kansas City Veterans Affairs Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical/New York-Presbyterian Hospital
      • Williamsville, New York, United States, 14226
        • Great Lakes Cancer Care
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Wake Forest Baptist Health - High Point Medical Center
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Outpatient Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital Cleveland Medical Center
      • Columbus, Ohio, United States, 43220
        • OSU Brain & Spine Hospital
    • South Dakota
      • North Sioux City, South Dakota, United States, 51101
        • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Experimental: SG + Pembrolizumab (Cohort B)
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Experimental: SG + Pembrolizumab + Carboplatin Safety Run-in
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Carboplatin
Administered intravenously
Other Names:
  • Paraplatin®
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Experimental: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Drug: Cisplatin
Administered intravenously
Other Names:
  • Platinol®
Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Carboplatin
Administered intravenously
Other Names:
  • Paraplatin®
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Drug: Cisplatin
Administered intravenously
Other Names:
  • Platinol®
Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Carboplatin
Administered intravenously
Other Names:
  • Paraplatin®
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Drug: Cisplatin
Administered intravenously
Other Names:
  • Platinol®
Experimental: SG + Pembrolizumab + Cisplatin (Cohort E)
Participants 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.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Drug: Pembrolizumab
Administered intravenously
Other Names:
  • KEYTRUDA®
Drug: Cisplatin
Administered intravenously
Other Names:
  • Platinol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 22 Months
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Time Frame: First dose date up to 21 days
First dose date up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Time Frame: Up to 24 Months
Up to 24 Months
Overall Survival
Time Frame: Up to 24 Months
Up to 24 Months
Duration of Response as Assessed by IRC per RECIST Version 1.1
Time Frame: Up to 24 Months
Up to 24 Months
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Time Frame: Up to 24 Months
Up to 24 Months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to 24 Months plus 30 days
First dose date up to 24 Months plus 30 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time Frame: First dose date up to 24 Months plus 30 days
First dose date up to 24 Months plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-576-6220
  • 2021-004280-27 (EudraCT Number)
  • KEYNOTE-D15 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-D15 (Other Identifier: Merck & Co., Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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