Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05186974
- Lead Sponsor
- Gilead Sciences
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 193
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Carboplatin 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. SG + Pembrolizumab + Cisplatin (Cohort E) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab (Cohort B) Pembrolizumab 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. Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A) Sacituzumab Govitecan-hziy (SG) 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. Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A) Pembrolizumab 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. SG + Pembrolizumab (Cohort B) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin Safety Run-in Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin Safety Run-in Pembrolizumab 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. SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) Pembrolizumab 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. SG + Pembrolizumab + Carboplatin Safety Run-in Carboplatin 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. SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) Cisplatin 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Sacituzumab Govitecan-hziy (SG) 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Pembrolizumab 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Carboplatin 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) Cisplatin 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Pembrolizumab 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. SG + Pembrolizumab + Cisplatin (Cohort E) Pembrolizumab 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. SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) Cisplatin 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. SG + Pembrolizumab + Cisplatin (Cohort E) Cisplatin 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.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method Progression-free Survival as Assessed by IRC per RECIST Version 1.1 Up to 24 Months Overall Survival Up to 24 Months Duration of Response as Assessed by IRC per RECIST Version 1.1 Up to 24 Months Disease Control Rate as Assessed by IRC per RECIST Version 1.1 Up to 24 Months Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) First dose date up to 24 Months plus 30 days Percentage of Participants Experiencing Clinical Laboratory Abnormalities First dose date up to 24 Months plus 30 days
Trial Locations
- Locations (101)
Queen Elizabeth Hospital
🇭🇰Hong Kong, Hong Kong
Institut Kanser Negara
🇲🇾Putrajaya, Malaysia
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Chang Gung Memorial Hospital (CGMH)
🇨🇳Taoyuan City, Taiwan
E-DA Hospital
🇨🇳Kaohsiung City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
OSU Brain & Spine Hospital
🇺🇸Columbus, Ohio, United States
Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH
🇩🇪Berlin, Germany
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Alaska Oncology and Hematology, LLC.
🇺🇸Anchorage, Alaska, United States
UC Irvine Health
🇺🇸Orange, California, United States
Wake Forest Baptist Health - High Point Medical Center
🇺🇸High Point, North Carolina, United States
St George Private Hospital
🇦🇺Kogarah, New South Wales, Australia
Pindara Private Hospital
🇦🇺Benowa, Queensland, Australia
CHU de CAEN
🇫🇷Caen, France
Kansas City Veterans Affairs Medical Center
🇺🇸Westwood, Kansas, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Saint Vincents Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Centre Jean Perrin - 58 rue Montalembert
🇫🇷Clermont-Ferrand, France
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Joondalup Health Campus
🇦🇺Joondalup, Western Australia, Australia
Clinique Victor Hugo
🇫🇷Le Mans, France
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Stanford Cancer Institute
🇺🇸Stanford, California, United States
Northside Hospital Central Research Department
🇺🇸Atlanta, Georgia, United States
Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie
🇩🇪Esslingen, Germany
Peninsula Health - Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Sunshine Coast University Private Hospital
🇦🇺Birtinya, Queensland, Australia
ASST Spedali Civili di Brescia
🇮🇹Brescia, Italy
UCLA Hematology/Oncology - Santa Monica
🇺🇸Los Angeles, California, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Ashford Cancer Centre Research
🇦🇺Windsor Gardens, South Australia, Australia
CIUSSS Saguenay Lac St-Jean
🇨🇦Quebec, Canada
Weill Cornell Medical/New York-Presbyterian Hospital
🇺🇸New York, New York, United States
APHP - Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
Hospital Raja Perempuan Zainab II
🇲🇾Kota Bharu, Malaysia
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
LungenClinic Grosshansdorf
🇩🇪Grosshansdorf, Germany
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Martha-Maria Krankenhaus Halle Dölau gGmbH
🇩🇪Halle, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
AOU Policlinico Vittorio Emanuele - POG Rodolico
🇮🇹Catania, Italy
CHU de Bordeaux Hopital Haut leveque
🇫🇷Pessac, France
Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario
🇪🇸Santiago de Compostela, Spain
Universitatsklinikum Koln, Klinik I fur Innere Medizin
🇩🇪Cologne, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
🇪🇸Majadahonda, Spain
Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie
🇩🇪Gauting, Germany
LKI Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Gachon University Gil Medical Center
🇰🇷Inchon, Korea, Republic of
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Regional Universitario de Malaga-Hospital Civil
🇪🇸Rincon de la Victoria, Spain
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Changhua Christian Hospital
🇨🇳Changhua City, Taiwan
IRCCS Instituto Clinico Humanitas
🇮🇹Rozzano, Italy
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
🇪🇸A coruna, Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Chi Mei Hospital - Liouying
🇨🇳Liouying Dist., Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
🇨🇳Taipei City, Taiwan
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Clinica Universidad de Navarra - Pamplona
🇪🇸Pamplona, Spain
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena
🇮🇹Rome, Italy
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Centre Francois Baclesse
🇫🇷Caen, France
Centre Georges-François Leclerc
🇫🇷Dijon, France
Institut Curie
🇫🇷Paris, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint Herblain, France
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
🇺🇸Aurora, Colorado, United States
CHRU de Brest - Hopital Morvan
🇫🇷Brest, France
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
University Hospital Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Great Lakes Cancer Care
🇺🇸Williamsville, New York, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
🇺🇸North Sioux City, South Dakota, United States
Southern Highlands Cancer Centre
🇦🇺Bowral, New South Wales, Australia
McGill University Health Centre
🇨🇦Quebec, Canada
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
🇫🇷Pierre Benite, France
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Sultan Ismail Hospital
🇲🇾Johor Bahru, Malaysia
The Catholic University of Korea St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Malaysia
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Western Health - Sunshine Hospital
🇦🇺Melbourne, Victoria, Australia
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Hong Kong United Oncology Center
🇭🇰Kowloon, Hong Kong