Lung Cancer Clinical Trial

Study of Sacituzumab Govitecan-hziy Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Summary

The primary objectives of the study are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin) in participants with advanced or metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

164

Study ID:

NCT05186974

Recruitment Status:

Recruiting

Sponsor:

Gilead Sciences

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There are 50 Locations for this study

See Locations Near You

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
University of California Los Angeles (UCLA)
Los Angeles California, 90404, United States
UC Irvine Medical Center
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
Northside Hospital Central Research Department
Atlanta Georgia, 30342, United States
Orchard Healthcare Research Inc.
Skokie Illinois, 60077, United States
Great Lakes Cancer Care
Williamsville New York, 14226, United States
FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
North Sioux City South Dakota, 51101, United States
Southern Highlands Cancer Center
Bowral New South Wales, 2576, Australia
Saint Vincents Hospital Sydney
Darlinghurst New South Wales, 2010, 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
Western Health - Sunshine Hospital
Melbourne Victoria, 3021, Australia
Joondalup Health Campus
Joondalup Western Australia, 6027, Australia
APHP - Hôpital Ambroise Paré
Boulogne-Billancourt , 92100, France
CHU de Caen Côte de Nacre
Caen , 14000, France
Clinique Victor Hugo Le Mans
Le Mans , 72000, France
CHU de Bordeaux Hopital Haut leveque
Pessac , 33604, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Klinikum Esslingen
Esslingen , 73730, Germany
Asklepios Fachkliniken Munchen-Gauting
Gauting , 82131, Germany
LungenClinic Grosshansdorf
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle Dölau
Halle , 06120, Germany
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 Mary Hospital
Hong Kong , , Hong Kong
Hong Kong United Oncology Center
Kowloon , , Hong Kong
Chungbuk National University Hospital
Cheongjusi , 28644, Korea, Republic of
Gachon University Gil Medical Center
Inchon , 21565, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
St. Vincent's Medical Center
Suwon , 16247, Korea, Republic of
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A coruna , 15006, Spain
Hospital Universitari Vall d'Hebrón
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitari Germans Trias i Pujol
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 , 31008, Spain
Hospital Regional Universitario de Malaga-Hospital Civil
Rincon 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
Sevilla , 41001, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City , 80756, Taiwan
E-DA Hospital
Kaohsiung City , 824, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 83301, Taiwan
Chi Mei Hospital - Liouying
Liouying Dist. , , Taiwan
National Cheng Kung University Hospital
Tainan City , , Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei City , 110, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

164

Study ID:

NCT05186974

Recruitment Status:

Recruiting

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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