Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).
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).
Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.
Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.
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 before randomization.
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:
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.
Fort Myers, Florida 33901, United States
Sioux City, Iowa 51101, United States
Innsbruck, 06020, Austria
Salzburg, A-5020, Austria
Vienna, 1210, Austria
São Paulo, 03102002, Brazil
Calvados, 14076 CEDEX 05, France
Epagny Metz-tessy, 74374, France
Saint-Herblain, 44805, France
Braunschweig, 38114, Germany
Esslingen am Neckar, 73730, Germany
Lübeck, 23538, Germany
Mannheim, 68167, Germany
Munchen-Gauting, 82131, Germany
Offenbach, 63069, Germany
Athens, 11527, Greece
Heraklion, Greece
Larissa, 413 34, Greece
Nea Kifissia, 14565, Greece
Kanagawaken, 236-0051, Japan
Kitaadachi-gun, 362-0806, Japan
Osakasayama-Shi, 589-8511, Japan
Shinjuku-Ku, 162-8655, Japan
Sunto-gun, 411-8777, Japan
Rotterrdam, 3015, Netherlands
Rzeszáw, 35-085, Poland
Siedlce, 08-110, Poland
Badalona, 08916, Spain
Dikimevi- Ankara, 06100, Turkey (Türkiye)
Birmingham, B9 5SS, United Kingdom