NCT05502237|Active Not RecruitingPhase 3DMCFDA Drug

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

STAR-121

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

Gilead Sciences ClinicalTrials.gov

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2 other identifiers

GS-US-626-62162022-000578-25

Study Type

interventional

Target

1,021

Locations

23 countries

Sites

186

Timeline

RegisteredAug 2022

StartedOct 2022

CompletionJan 2029

Brief Summary

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,021

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline

33mo left

Started Oct 2022

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

23 countries

186 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.2 years study duration

Study Progress57%

Oct 2022Jan 2029

First Submitted

Initial submission to the registry

August 12, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

August 12, 2022

Last Update Submit

January 28, 2026

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (≥1%Tumor Cells) and in all Randomized Participants.
OS is defined as the time from the date of randomization to the date of death from any cause.
Up to 68 months

Secondary Outcomes (6)

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
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
First dose date up to 50 months plus 30 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
First dose date up to 50 months plus 30 days
+1 more secondary outcomes

Study Arms (3)

Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

EXPERIMENTAL

Participants 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.

Drug: ZimberelimabDrug: DomvanalimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-paclitaxelDrug: Pemetrexed

Pembrolizumab (PEMBRO) + Chemotherapy

ACTIVE COMPARATOR

Participants 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.

Drug: PembrolizumabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-paclitaxelDrug: Pemetrexed

Zimberelimab (ZIM) + Chemotherapy

EXPERIMENTAL

Participants 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.

Drug: ZimberelimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-paclitaxelDrug: Pemetrexed

Interventions

DomvanalimabDRUG

Administered intravenously

Also known as: GS-0154, AB154

Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy

PembrolizumabDRUG

Administered intravenously

Also known as: KEYTRUDA®

Pembrolizumab (PEMBRO) + Chemotherapy

CarboplatinDRUG

Administered intravenously