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

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05186974
• Other study ID #: GS-US-576-6220
• Secondary ID: 2021-004280-27KE
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 30, 2022
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (NSCLC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 193
• Est. completion date: February 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Sacituzumab Govitecan-hziy (SG)
Administered intravenously
• Pembrolizumab
Administered intravenously
• Carboplatin
Administered intravenously
• Cisplatin
Administered intravenously

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	Sunshine Coast University Private Hospital	Birtinya	Queensland
Australia	Southern Highlands Cancer Centre	Bowral	New South Wales
Australia	Saint Vincents Hospital Sydney	Darlinghurst	New South Wales
Australia	Peninsula Health - Frankston Hospital	Frankston	Victoria
Australia	Joondalup Health Campus	Joondalup	Western Australia
Australia	St George Private Hospital	Kogarah	New South Wales
Australia	Western Health - Sunshine Hospital	Melbourne	Victoria
Australia	Ashford Cancer Centre Research	Windsor Gardens	South Australia
Canada	CIUSSS Saguenay Lac St-Jean	Quebec
Canada	McGill University Health Centre	Quebec
France	APHP - Hôpital Ambroise Paré	Boulogne-Billancourt
France	CHRU de Brest - Hopital Morvan	Brest
France	Centre Francois Baclesse	Caen
France	CHU de CAEN	Caen
France	Centre Jean Perrin - 58 rue Montalembert	Clermont-Ferrand
France	Centre Georges-François Leclerc	Dijon
France	Clinique Victor Hugo	Le Mans
France	Institut Curie	Paris
France	CHU de Bordeaux Hopital Haut leveque	Pessac
France	Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud	Pierre Benite
France	Institut de Cancérologie de l'Ouest	Saint Herblain
Germany	Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitatsklinikum Koln, Klinik I fur Innere Medizin	Cologne
Germany	Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie	Esslingen
Germany	Universitatsklinikum Frankfurt	Frankfurt
Germany	Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie	Gauting
Germany	LungenClinic Grosshansdorf	Grosshansdorf
Germany	Martha-Maria Krankenhaus Halle Dölau gGmbH	Halle
Germany	LKI Lungenfachklinik Immenhausen	Immenhausen
Hong Kong	Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Hong Kong United Oncology Center	Kowloon
Italy	ASST Spedali Civili di Brescia	Brescia
Italy	AOU Policlinico Vittorio Emanuele - POG Rodolico	Catania
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena	Rome
Italy	IRCCS Instituto Clinico Humanitas	Rozzano
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Gachon University Gil Medical Center	Inchon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul Metropolitan Government - Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon
Malaysia	Sultan Ismail Hospital	Johor Bahru
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Institut Kanser Negara	Putrajaya
Spain	Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera	A coruna
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitari Vall d'Hebrón	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda
Spain	Clinica Universidad de Navarra - Pamplona	Pamplona
Spain	Hospital Regional Universitario de Malaga-Hospital Civil	Rincon de la Victoria
Spain	Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario	Santiago de Compostela
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	E-DA Hospital	Kaohsiung City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Chi Mei Hospital - Liouying	Liouying Dist.
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Taipei City
Taiwan	Chang Gung Memorial Hospital (CGMH)	Taoyuan City
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United States	Alaska Oncology and Hematology, LLC.	Anchorage	Alaska
United States	Northside Hospital Central Research Department	Atlanta	Georgia
United States	University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)	Aurora	Colorado
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospital Cleveland Medical Center	Cleveland	Ohio
United States	OSU Brain & Spine Hospital	Columbus	Ohio
United States	Wake Forest Baptist Health - High Point Medical Center	High Point	North Carolina
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	UCLA Hematology/Oncology - Santa Monica	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Weill Cornell Medical/New York-Presbyterian Hospital	New York	New York
United States	Siouxland Regional Cancer Center dba June E. Nylen Cancer Center	North Sioux City	South Dakota
United States	UC Irvine Health	Orange	California
United States	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Stanford Cancer Institute	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Kansas City Veterans Affairs Medical Center	Westwood	Kansas
United States	Great Lakes Cancer Care	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Hong Kong,  Italy,  Korea, Republic of,  Malaysia,  Spain,  Taiwan,  United Kingdom, 

Outcome

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

External Links

•   Gilead Clinical Trials Website