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History of Changes for Study: NCT05089734
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
Latest version (submitted June 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 11, 2021 None (earliest Version on record)
2 November 2, 2021 Study Status and References
3 December 3, 2021 Recruitment Status, Study Status and Contacts/Locations
4 December 9, 2021 Study Status and Study Identification
5 January 12, 2022 Study Status and Contacts/Locations
6 February 3, 2022 Contacts/Locations and Study Status
7 February 24, 2022 Study Status and Contacts/Locations
8 March 17, 2022 Study Status and Contacts/Locations
9 April 12, 2022 Contacts/Locations and Study Status
10 May 12, 2022 Study Status and Contacts/Locations
11 June 10, 2022 Contacts/Locations and Study Status
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Study NCT05089734
Submitted Date:  October 11, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: GS-US-577-6153
Brief Title: 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
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
Secondary IDs: 2021-003578-30 [EudraCT Number]
Open or close this module Study Status
Record Verification: October 2021
Overall Status: Not yet recruiting
Study Start: December 2021
Primary Completion: May 2024 [Anticipated]
Study Completion: January 2025 [Anticipated]
First Submitted: October 11, 2021
First Submitted that
Met QC Criteria:
October 11, 2021
First Posted: October 22, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
October 11, 2021
Last Update Posted: October 22, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

Detailed Description:
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 520 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Gilead Clinical Study Information Center
Telephone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Study Officials: Gilead Study Director
Study Director
Gilead Sciences
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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