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Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Study acronym: STAR-121
StatusActive, Not Recruiting
PhasePhase 3
Started2022-10-12
View on ClinicalTrials.gov ↗

Amendment history

2026-01-28
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v34
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 1069→confirmed 1021
Study sites227→186
2026-01-14
Study Status, Contacts/Locations v33
Completion date2028-06→2029-01
Study sitesdetails revised at 13 of 227 sites
2025-11-25
Study Status, Contacts/Locations v32
Study sitesdetails revised at 36 of 227 sites
2025-09-15
Study Status, Contacts/Locations v31
Study sitesdetails revised at 1 of 227 sites
2025-08-21
Study Status, Contacts/Locations v30
Study sitesdetails revised at 11 of 227 sites
Show 29 earlier versions
2025-07-21
Study Status, Contacts/Locations v29
Study sites225→227
2025-05-16
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v28
Trial statusActive, Not Recruiting→Recruiting
Study sites221→225
2025-01-17
Study Status, Study Description, Study Design, Outcome Measures v27
Primary completion date2027-09→2028-06
Completion date2027-09→2028-06
Enrollment target792→1069
Secondary endpoints5 to 6 entries
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Primary endpoints2 to 1 entries
Overall Survival (OS) Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in SolidParticipants TumorsWith Positive Programmed Cell Death-Ligand 1 (RECISTPD-L1) VersionExpression (≥1%Tumor Cells) and in all Randomized Participants.1
2024-11-07
Study Status, Outcome Measures v26
Re-verified, no change to tracked fields
2024-08-14
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 720→confirmed 792
Study sites224→221
2024-07-01
Study Status v24
Re-verified, no change to tracked fields
2024-06-26
Study Status, Contacts/Locations v23
Study sites207→224
2024-04-30
Study Status, Contacts/Locations v22
Study sites202→207
2024-04-05
Study Status, Arms and Interventions, Contacts/Locations v21
Primary completion date2027-12→2027-09
Completion date2027-12→2027-09
Study sites186→202
2024-02-21
Study Status, Contacts/Locations v20
Study sites184→186
2024-02-02
Study Status, Contacts/Locations v19
Study sites173→184
2024-01-09
Study Status, Contacts/Locations v18
Study sites158→173
2023-12-14
Study Status, Contacts/Locations v17
Study sites148→158
2023-11-29
Study Status, Contacts/Locations v16
Study sites142→148
2023-11-06
Study Status, Contacts/Locations v15
Study sites130→142
2023-10-13
Study Status, Contacts/Locations v14
Study sites122→130
2023-09-14
Study Status, Eligibility, Contacts/Locations v13
Study sites113→122
Eligibility criteria-37 characters
[...] FR) and anaplastic lymphoma kinase (ALK) mutations. Have no knownactionable genomic alterations insuch as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor [...] NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved frontline therapies (actionable genomic alteration). Have not received prior systemic treatment for metastatic NSCLC. Measurable disease by CT or MRI as per RECIST v1.1 criteria by investigator assessment. Easter [...] tus (ECOG PS) score of 0 or 1. Have adequate organ functions. Key Exclusion Criteria: Have mixed small-cell lung cancer ( [...] [...]
2023-08-21
Study Status, Contacts/Locations v12
Study sites106→113
2023-07-27
Study Status, Contacts/Locations v11
Study sites85→106
2023-06-23
Study Status, Contacts/Locations v10
Study sites59→85
2023-04-26
Study Status, Contacts/Locations v9
Study sites36→59
2023-03-14
Study Status, Arms and Interventions, Contacts/Locations v8
Study sites22→36
InterventionsCarboplatin (Drug), Cisplatin (Drug), Domvanalimab (Biological), Nab-paclitaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Biological)…→Carboplatin (Drug), Cisplatin (Drug), Domvanalimab (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed…
2023-02-03
Study Status, Contacts/Locations v7
Study sites18→22
2023-01-11
Study Status, Contacts/Locations v6
Study sites8→18
2022-12-13
Study Status, Contacts/Locations v5
Study sites5→8
2022-11-22
Study Status, Contacts/Locations v4
Study sites4→5
2022-11-04
Study Status, Contacts/Locations v3
Start dateestimated 2022-10→confirmed 2022-10-12
Study sites1→4
2022-10-07
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
InterventionsCarboplatin (Drug), Cisplatin (Drug), Domvanalimab (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed…→Carboplatin (Drug), Cisplatin (Drug), Domvanalimab (Biological), Nab-paclitaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Biological)…
2022-08-29
Study Status, References v1
2022-08-12
Original filing
The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.
Trial Details
NCT Number NCT05502237
Lead Sponsor Gilead Sciences
Collaborators: Arcus Biosciences, Inc.
Conditions Non-small Cell Lung Cancer
Enrollment 1,021 participants
Start Date 2022-10-12
Primary Completion 2028-06 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-30