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 D

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Docetaxel

Criteria

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

• Trop-2-targeted therapy

• 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.