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Zimberelimab

Phase 3

Non-small Cell Lung Cancer | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Jul 9, 2026

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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,021
FDA Designations
No designations recorded
Clinical trial landscape

Zimberelimab · 3 trials · 7 indications

Phase 3 1Phase 2 2
NCT05502237Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung CancerNon-small Cell Lung Cancer
ACTIVE NOT_RECRUITING1,021 Analytics
PHASE3ACTIVE NOT_RECRUITING
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
Non-small Cell Lung CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (≥1%Tumor Cells) and in all Randomized Participants.
Up to 68 months

OS is defined as the time from the date of randomization to the date of death from any cause.

Estimate the progression free survival (PFS) with gemcitabine, cisplatin, quemliclustat (AB680) and zimberelimab (AB122) in patients with advanced BTCs.
2 years

Progression free survival (PFS), as determined by RECIST v1.1, is defined as the time from study registration to the date of documented disease progression or death from any cause.

Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Up to 5 years

ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.

Substudy 03: Complete Pathological Response (pCR) Rate
Up to 5 years

pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.

Secondary Endpoints
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Upt to 50 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Up to 50 Months
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Up to 50 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Zimberelimab (ZIM) +Domvanalimab (DOM) + ChemotherapyEXPERIMENTALParticipants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles.
Pembrolizumab (PEMBRO) + ChemotherapyACTIVE_COMPARATORParticipants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin AUC 5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles.
Zimberelimab (ZIM) + ChemotherapyEXPERIMENTALParticipants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m\^2 or carboplatin AUC 5 + pemetrexed 500 mg/m\^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m\^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m\^2 Q3W or nab-paclitaxel 100 mg/m\^2 weekly (QW) for first 4 cycles.
Arm AEXPERIMENTALQuemliclustat (AB680), zimberelimab (AB122), gemcitabine, and cisplatin in subjects with untreated advanced BTC. Quemliclustat IV: Day 1, 15, and 29 of each cycle; Zimberelimab IV: Day 1 and 22 of each cycle; Gemcitabine IV: Day 1, 8, 22 and 29 of each cycle; Cisplatin IV: Day 1, 8, 22 and 29 of Cycles 1-4 only.
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)EXPERIMENTALParticipants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)EXPERIMENTALParticipants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Substudy 01: ZIM + ETRUMAEXPERIMENTALParticipants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)EXPERIMENTALParticipants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Substudy 01: ZIM + Platinum Based ChemotherapyACTIVE_COMPARATORExpansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology).
Substudy 02: SG + ZIM + ETRUMAEXPERIMENTALParticipants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Substudy 02: Either Docetaxel or SG (Monotherapy Only)ACTIVE_COMPARATORParticipants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Substudy 03 - ZIM + DOM + Platinum-based ChemotherapyEXPERIMENTALParticipants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Substudy 03 - ZIM + Platinum-based ChemotherapyEXPERIMENTALParticipants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Substudy 03: Nivolumab + Platinum-based ChemotherapyACTIVE_COMPARATORParticipants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Interventions
NameTypeDescription
ZimberelimabDRUGAdministered intravenously
DomvanalimabDRUGAdministered intravenously
PembrolizumabDRUGAdministered intravenously
CarboplatinDRUGAdministered intravenously
CisplatinDRUGAdministered intravenously
PaclitaxelDRUGAdministered intravenously
Nab-paclitaxelDRUGAdministered intravenously
PemetrexedDRUGAdministered intravenously
GemcitabineDRUGGemcitabine IV: Day 1, 8, 22, and 29 every 42 days
QuemliclustatDRUGQuemliclustat IV: Day 1, 15, 29 every 42 days
Zimberelimab (ZIM)DRUGAdministered intravenously
Domvanalimab (DOM)DRUGAdministered intravenously
Sacituzumab govitecan-hziy (SG)DRUGAdministered intravenously
Etrumadenant (ETRUMA)DRUGAdministered orally
DocetaxelDRUGAdministered intravenously
NivolumabDRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites186

Key Inclusion Criteria: * Life expectancy ≥ 3 months. * Pathologically documented NSCLC that meets both of the criteria below: * Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition). * Have documented ...

Countries:United StatesArgentinaAustriaBelgiumBrazilCanadaChileChinaFranceGermanyHong KongIsraelItalyJapanMexicoNetherlandsPortugalSingaporeSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 395 trials
Recent Changes (Last 90 Days)
MEDIUMJul 9, 2026NCT06048133Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 9, 2026NCT06048133Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJun 2, 2026NCT05633667Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJun 2, 2026NCT05633667Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJun 2, 2026NCT05633667Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06048133primaryCompletionDate: changed
LOWMay 26, 2026NCT05633667primaryCompletionDate: changed
LOWMay 26, 2026NCT05502237primaryCompletionDate: changed
LOWMay 24, 2026NCT06048133studyFirstPostDate: changed
LOWMay 24, 2026NCT05633667studyFirstPostDate: changed
LOWMay 24, 2026NCT05502237studyFirstPostDate: changed