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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 (EVOKE-01)

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ClinicalTrials.gov Identifier: NCT05089734
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Sacituzumab Govitecan-hziy (SG) Drug: Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sacituzumab Govitecan-hziy (SG)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Drug: Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132

Active Comparator: Docetaxel
Participants will receive docetaxel 75 mg/m^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Drug: Docetaxel
Administered intravenously




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 30 months ]
    OS is defined as the time from the date of randomization until the date of death from any cause.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 30 months ]
    PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first.

  2. Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ]
    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.

  3. Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ]
    DOR is defined as time from first documented CR or PR to the earlier of the first documented PD or death from any cause (whichever comes first)

  4. Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ]
    DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1.

  5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 30 months plus 30 days ]
  6. Percentage of Participants Experiencing Laboratory abnormalities [ Time Frame: First dose date up to 30 months plus 30 days ]
  7. Mean Change From Baseline in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score [ Time Frame: Baseline, Up to 30 Months ]
    The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.

  8. Mean Change From Baseline in Shortness of Breath as Measured by NSCLC-SAQ [ Time Frame: Baseline, Up to 30 Months ]
    The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The dyspnea (shortness of breath) item uses a "Never to Always" rating scale with higher score indicating higher frequency of dyspnea.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05089734


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Additional Information:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05089734    
Other Study ID Numbers: GS-US-577-6153
2021-003578-30 ( EudraCT Number )
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action