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Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Study acronym: EVOKE-01
StatusActive, Not Recruiting
PhasePhase 3
Started2021-11-17
View on ClinicalTrials.gov ↗

Amendment history

2026-04-22
Study Status v29
Completion date2026-01→2027-01
2025-05-13
Study Status v28
Completion date2025-05→2026-01
2025-01-13
Study Status, Baseline Characteristics, Adverse Events v27
Results first postednot stated→2025-01-14
2024-11-27
Study Identification, Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v26
Completion date2025-03→2025-05
Secondary endpoints8 entries, revised
Progression-free Survival (PFS) Assessed by Investigator perPer Response Evaluation Criteria in Solid Tumors (RECIST) Versi [...] 1.1 Objective Response Rate (ORR) Assessed by Investigator perPer RECIST Version 1.1 Duration of Response (DOR) Assessed by Investigator perPer RECIST Version 1.1 Disease Control Rate (DCR) Assessed by Investigator perPer RECIST Version 1.1 Percentage of Participants ExperiencingWho Experienced Treatment-emergent Emergent Adverse Events (TEAEs) Percentage of Participants ExperiencingWho Experienced Grade 3 or 4 Treatment Emergent Laboratory abnormalitiesAbnormalities Post [...] [...]
2024-05-29
Study Status v25
Re-verified, no change to tracked fields
Show 24 earlier versions
2024-02-19
Study Status, Study Design v24
Primary completion dateestimated 2024-05→confirmed 2023-11-29
Enrollment targetestimated 580→confirmed 603
2023-12-06
Study Status v23
Re-verified, no change to tracked fields
2023-06-28
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v22
Trial statusRecruiting→Active, Not Recruiting
Completion date2025-01→2025-03
Study sites228→227
2023-04-21
Study Status, Contacts/Locations v21
Study sites224→228
2023-03-24
Study Identification, Study Status, Study Description, Contacts/Locations v20
Study sites202→224
Study title-153 characters
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
2023-01-20
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v19
Enrollment target520→580
Study sites185→202
InterventionsDocetaxel (Drug), Sacituzumab Govitecan-hziy (SG) (Drug)→Docetaxel (Drug), Sacituzumab Govitecan-hziy (SG) (Biological)
Eligibility criteria+192 characters
[...] on the American Joint Committee on Cancer, Eighth Edition). Testing for epidermalEpidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) isresults are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and [...] al 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-b [...] [...]
Secondary endpoints8 entries, revised
MeanTime Changeto FromFirst BaselineDeterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score MeanTime Changeto FromFirst BaselineDeterioration in Shortness of Breath as Measured by NSCLC-SAQ Total Score
2022-12-22
Study Identification, Study Status, Contacts/Locations v18
Study sites176→185
2022-12-02
Study Status, Contacts/Locations v17
Study sites171→176
2022-11-07
Study Status, Contacts/Locations v16
Study sites158→171
2022-10-21
Study Status, Contacts/Locations v15
Study sites141→158
2022-09-27
Study Status, Contacts/Locations v14
Study sites129→141
2022-08-17
Study Status, Contacts/Locations v13
Study sites105→129
2022-07-20
Study Status, Contacts/Locations v12
Study sites99→105
2022-07-01
Study Status, Contacts/Locations v11
Study sites92→99
2022-06-10
Study Status, Contacts/Locations v10
Study sites69→92
2022-05-12
Study Status, Contacts/Locations v9
Study sites47→69
2022-04-12
Study Status, Contacts/Locations v8
Study sites36→47
2022-03-17
Study Status, Contacts/Locations v7
Study sites28→36
2022-02-24
Study Status, Contacts/Locations v6
Study sites23→28
2022-02-03
Study Status, Contacts/Locations v5
Study sites19→23
2022-01-12
Study Status, Contacts/Locations v4
Study sites2→19
2021-12-09
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2021-12-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-12→confirmed 2021-11-17
Study sites0→2
2021-11-02
Study Status, References v1
Re-verified, no change to tracked fields
2021-10-11
Original filing
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).
Trial Details
NCT Number NCT05089734
Lead Sponsor Gilead Sciences
Conditions Non-Small Cell Lung Cancer
Enrollment 603 participants
Start Date 2021-11-17
Primary Completion 2023-11-29 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-07