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

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sacituzumab Govitecan-hziy (SG)
Pembrolizumab
Carboplatin
Cisplatin
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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
  • Chungbuk National University Hospital
  • Gachon University Gil Medical Center
  • Asan Medical Center
  • Seoul Metropolitan Government - Seoul National University Boramae Medical Center
  • Severance Hospital, Yonsei University Health System
  • The Catholic University of Korea St. Vincent's Hospital
  • Sultan Ismail Hospital
  • Hospital Raja Perempuan Zainab II
  • Hospital Kuala Lumpur
  • University Malaya Medical Centre
  • Hospital Tengku Ampuan Afzan
  • Sarawak General Hospital
  • Institut Kanser Negara
  • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitari Vall d'Hebrón
  • Hospital Clinic de Barcelona
  • Hospital Duran i Reynals
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Clinica Universidad de Navarra - Pamplona
  • Hospital Regional Universitario de Malaga-Hospital Civil
  • Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario
  • Hospital Universitario Virgen de Valme
  • Hospital Universitario Virgen Macarena
  • Hospital Universitari i Politecnic La Fe
  • Changhua Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • E-DA Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Chi Mei Hospital - Liouying
  • National Cheng Kung University Hospital
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital (CGMH)
  • University Hospitals Birmingham NHS Foundation Trust
  • Guy's and St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)

SG + Pembrolizumab (Cohort B)

SG + Pembrolizumab + Carboplatin Safety Run-in

SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)

SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)

SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)

SG + Pembrolizumab + Cisplatin (Cohort E)

Arm Description

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts

Secondary Outcome Measures

Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Overall Survival
Duration of Response as Assessed by IRC per RECIST Version 1.1
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities

Full Information

First Posted
December 23, 2021
Last Updated
September 29, 2023
Sponsor
Gilead Sciences
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05186974
Brief Title
Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
Acronym
EVOKE-02
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
Arm Type
Experimental
Arm Description
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.
Arm Title
SG + Pembrolizumab (Cohort B)
Arm Type
Experimental
Arm Description
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.
Arm Title
SG + Pembrolizumab + Carboplatin Safety Run-in
Arm Type
Experimental
Arm Description
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.
Arm Title
SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
Arm Type
Experimental
Arm Description
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.
Arm Title
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
Arm Type
Experimental
Arm Description
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.
Arm Title
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
Arm Type
Experimental
Arm Description
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.
Arm Title
SG + Pembrolizumab + Cisplatin (Cohort E)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan-hziy (SG)
Other Intervention Name(s)
GS-0132, IMMU-132
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol®
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Progression-free Survival as Assessed by IRC per RECIST Version 1.1
Time Frame
Up to 24 Months
Title
Overall Survival
Time Frame
Up to 24 Months
Title
Duration of Response as Assessed by IRC per RECIST Version 1.1
Time Frame
Up to 24 Months
Title
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Time Frame
Up to 24 Months
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
First dose date up to 24 Months plus 30 days
Title
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time Frame
First dose date up to 24 Months plus 30 days

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-576-6220
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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