Lung Cancer Clinical Trial
Study of Sacituzumab Govitecan-hziy (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-programmed Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Immunotherapy
The primary objective of this study is to compare overall survival (OS) of sacituzumab govitecan-hziy (SG) versus docetaxel in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/ programmed death ligand 1 (PD-L1) immunotherapy received either in combination or sequentially.
Participants will be randomly assigned in a 1:1 ratio to receive either SG or docetaxel.
Key Inclusion Criteria:
Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
Testing for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death ligand 1 (PD-L1) is required. Testing for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment.
Must have progressed after platinum-based chemotherapy in combination with anti-PD-L1 antibody OR platinum-based chemotherapy and anti-PD-L1 antibody (in either order) sequentially.
No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 approved tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm^3, and platelets ≥ 100,000/μL).
Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).
Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Key Exclusion Criteria:
Mixed small-cell lung cancer and NSCLC histology.
Positive serum pregnancy test or women who are lactating.
Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.
Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.
Previously received treatment with any of the following:
Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
Docetaxel as monotherapy or in combination with other agents
Active second malignancy
NSCLC that is eligible for definitive local therapy alone.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Active cardiac disease
Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
Active serious infection requiring antibiotics.
Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.
Positive hepatitis C antibody and detectable hepatitis C viral load.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 159 Locations for this study
Anchorage Alaska, 99508, United States
Tucson Arizona, 85711, United States
Beverly Hills California, 90211, United States
Aurora Colorado, 80012, United States
Fort Myers Florida, 33901, United States
Pensacola Florida, 32503, United States
Saint Petersburg Florida, 33705, United States
West Palm Beach Florida, 33401, United States
Chicago Illinois, 60607, United States
Niles Illinois, 60714, United States
Sioux City Iowa, 51101, United States
Westwood Kansas, 66205, United States
Lexington Kentucky, 40503, United States
Clinton Maryland, 20735, United States
Burlington Massachusetts, 01805, United States
Saint Paul Minnesota, 55101, United States
Lincoln Nebraska, 68506, United States
Henderson Nevada, 89052, United States
Johnson City New York, 13790, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28204, United States
Pinehurst North Carolina, 28374, United States
Salisbury North Carolina, 28144, United States
Columbus Ohio, 43219, United States
Chattanooga Tennessee, 37404, United States
Memphis Tennessee, 38120, United States
Bedford Texas, 76022, United States
Denison Texas, 75020, United States
Denton Texas, 76201, United States
McAllen Texas, 78503, United States
McKinney Texas, 75071, United States
Paris Texas, 75460, United States
Plano Texas, 75075, United States
Plano Texas, 75093, United States
Winchester Virginia, 22601, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Albury New South Wales, 2640, Australia
Bowral New South Wales, 2576, Australia
Darlinghurst New South Wales, 2010, Australia
Greenslopes Queensland, 4120, Australia
Bedford Park South Australia, 5042, Australia
Hobart Tasmania, 7000, Australia
Box Hill Victoria, 3128, Australia
Clayton Victoria, 3168, Australia
Frankston Victoria, 3199, Australia
Perth Western Australia, 6009, Australia
Salzburg , 5020, Austria
Salzburg , A-502, Austria
Vienna , 1210, Austria
Brasschaat , 2930, Belgium
Brussels , 1200, Belgium
Edegem , 2650, Belgium
Mons , 7000, Belgium
Fortaleza , 60810, Brazil
Ijui , 98700, Brazil
Itajai , 88331, Brazil
Jau , 17210, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90110, Brazil
Sao Paolo , , Brazil
Sao Paulo , 03102, Brazil
São Paulo , , Brazil
Barrie , L4M 6, Canada
Brampton , L6R 3, Canada
Montreal , H4A 3, Canada
Rimouski , G5L5T, Canada
Windsor , N8W 2, Canada
Avignon , 84918, France
Bayonne , 64100, France
Boulogne-Billancourt , 92100, France
Caen , 14033, France
Calvados , 14076, France
Chauny , 02300, France
Clermont Ferrand , 63000, France
Creteil , 94010, France
Epagny Metz-tessy , 74374, France
La Roche-sur-Yon , 85925, France
Le Mans , 72000, France
Lille , 59000, France
Montpellier , 34295, France
Mulhouse , 68100, France
Paris cedex 05 , , France
Pierre Benite , 69495, France
Saint Herblain , , France
Toulon cedex , 83056, France
Braunschweig , 38114, Germany
Esslingen , 73730, Germany
Gauting , 82131, Germany
Hamburg , 21075, Germany
Hamburg , , Germany
Heilbronn , 74245, Germany
Immenhausen , 34376, Germany
Kassel , 34125, Germany
Mannheim , 68167, Germany
Offenbach , 63069, Germany
Athens , 11526, Greece
Athens , 11527, Greece
Cholargos , 15562, Greece
Heraklion , , Greece
Larisa , 413 3, Greece
NEA Kifissia , 14565, Greece
Thessaloniki , 54645, Greece
Thessaloniki , 555 3, Greece
Beer Seva , 84101, Israel
Jerusalem , , Israel
Rehovot , 76100, Israel
Tzrifin , , Israel
Bergamo , 24127, Italy
Catania , 95125, Italy
Catanzaro , 88100, Italy
Cremona , 26100, Italy
Milano , 20141, Italy
Milano , 20162, Italy
Pavia , 27100, Italy
Roma , 00128, Italy
San Giovanni Rotondo , 71013, Italy
Treviglio (Bg) , 24047, Italy
Varese , 21100, Italy
Hyogo , 670-8, Japan
Koto , 135-8, Japan
Ciudad de Mexico , 06100, Mexico
Guadalajara , 44670, Mexico
Guadalajara , , Mexico
Breda , 4818 , Netherlands
Den Haag , 2262B, Netherlands
Maastricht , 6229 , Netherlands
Tilburg , 5022, Netherlands
Konin , 62-50, Poland
Lodz , 90-30, Poland
Rzeszáw , 35-08, Poland
Siedlce , 08-11, Poland
Lisboa , 1769-, Portugal
Lisbon , , Portugal
Matosinhos , 4464-, Portugal
Porto , 14341, Portugal
Porto , 4200-, Portugal
Ponce , 00717, Puerto Rico
San Juan , 00902, Puerto Rico
A coruna , 15006, Spain
Badalona , 08916, Spain
Barakaldo , 48903, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Cáceres , 10004, Spain
Girona , 17007, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28020, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Murcia , 30120, Spain
Pamplona , 31008, Spain
Sabadell , 8208, Spain
Sevilla , 41001, Spain
Sevilla , 41009, Spain
Valencia , 46026, Spain
Ankara , 06520, Turkey
Bursa , 16059, Turkey
Dikimevi- Ankara , 06100, Turkey
Edirne , , Turkey
Istanbul , , Turkey
Kadikoy , , Turkey
Sariyer , , Turkey
Yenimahalle , , Turkey
Birmingham , B9 5S, United Kingdom
Colchester , CO4 5, United Kingdom
Glasgow , G12 0, United Kingdom
Leeds , LS9 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
Manchester , M20 4, United Kingdom
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