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 (EVOKE-01)

  • STATUS
    Recruiting
  • End date
    Jan 18, 2025
  • participants needed
    520
  • sponsor
    Gilead Sciences
Updated on 18 October 2022
tyrosine
measurable disease
growth factor
kinase inhibitor
neutrophil count
epidermal growth factor receptor
EGFR
docetaxel
cancer chemotherapy
epidermal growth factor
platinum-based chemotherapy
lung carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment docetaxel, Sacituzumab Govitecan-hziy (SG)
Clinical Study IdentifierNCT05089734
SponsorGilead Sciences
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

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
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

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
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