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A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509825-38-00
Acronym
GS-US-626-6216
Enrollment
322
Registered
2024-07-17
Start date
2022-12-01
Completion date
Unknown
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Non–Small Cell Lung Cancer

Brief summary

OS is defined as the time from the date of randomization to the date of death from any cause (both in participants with positive PD-L1 expression [≥ 1% TC] and in all randomized participants as dual primary endpoints)

Detailed description

PFS is defined as the time from the date of randomization until progressive disease (PD) as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first. ‌, ‌ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by BICR according to RECIST v1.1, DOR is defined as the time from the first response (CR or PR), to the first documented PD, as assessed by BICR according to RECIST v1.1, or death from any cause, whichever comes first.‌, Incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities, Time to first symptom deterioration in NSCLC SAQ shortness of breath domain, Time to first deterioration in NSCLC-SAQ total score

Interventions

DRUGCISPLATIN
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGDOMVANALIMAB
DRUGZimberelimab
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
DRUGCARBOPLATIN
DRUGPACLITAXEL

Sponsors

Gilead Sciences Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS is defined as the time from the date of randomization to the date of death from any cause (both in participants with positive PD-L1 expression [≥ 1% TC] and in all randomized participants as dual primary endpoints)

Secondary

MeasureTime frame
PFS is defined as the time from the date of randomization until progressive disease (PD) as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first. ‌, ‌ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by BICR according to RECIST v1.1, DOR is defined as the time from the first response (CR or PR), to the first documented PD, as assessed by BICR according to RECIST v1.1, or death from any cause, whichever comes first.‌, Incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities, Time to first symptom deterioration in NSCLC SAQ shortness of breath domain, Time to first deterioration in NSCLC-SAQ total score

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026