NCT05502237 (STAR-121) is a Phase 3 clinical trial of Zimberelimab in Non-small Cell Lung Cancer, sponsored by Gilead Sciences.

Who is sponsoring NCT05502237?

NCT05502237 is sponsored by Gilead Sciences.

What drugs are being tested in NCT05502237?

Interventions in NCT05502237: Zimberelimab, Domvanalimab, Pembrolizumab, Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel, Pemetrexed.

What condition does NCT05502237 study?

NCT05502237 studies Non-small Cell Lung Cancer.

Is NCT05502237 still recruiting?

NCT05502237 is currently active, enrolled. Last updated 28 January 2026.

Last reviewed 2026-01-28 · How we verify

NCT05502237: STAR-121

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 28 January 2026

What this trial tests

Phase 3 trial testing Zimberelimab in Non-small Cell Lung Cancer in 1,021 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 October 2022

Primary endpoint
1 June 2028

1 January 2029

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,021
Start date	12 October 2022
Primary completion	1 June 2028
Estimated completion	1 January 2029
Sites	186 locations across United States, Argentina, Austria, Belgium, Brazil, Canada, Chile, China

Drugs / interventions tested

Zimberelimab
Domvanalimab
Pembrolizumab (pembrolizumab) — full drug profile →
Carboplatin
Cisplatin (cisplatin) — full drug profile →
Paclitaxel — full drug profile →
Nab-paclitaxel
Pemetrexed — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Co-inhibition of TIGIT and PD-1/PD-L1 in Cancer Immunotherapy: Mechanisms and Clinical Trials.
Chu X, Tian W, Wang Z, Zhang J, et al · · 2023 · cited 147× · PMID 37291608 · DOI 10.1186/s12943-023-01800-3
Anti-TIGIT therapies for solid tumors: a systematic review.
Rousseau A, Parisi C, Barlesi F. · · 2023 · cited 111× · PMID 36933320 · DOI 10.1016/j.esmoop.2023.101184
Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.
Glaviano A, Lau HS, Carter LM, Lee EHC, et al · · 2025 · cited 90× · PMID 39806516 · DOI 10.1186/s13045-024-01634-6
Targeting TIGIT for cancer immunotherapy: recent advances and future directions.
Zhang P, Liu X, Gu Z, Jiang Z, et al · · 2024 · cited 69× · PMID 38229100 · DOI 10.1186/s40364-023-00543-z
Current Landscape of Cancer Immunotherapy: Harnessing the Immune Arsenal to Overcome Immune Evasion.
Mitra A, Kumar A, Amdare NP, Pathak R. · · 2024 · cited 34× · PMID 38785789 · DOI 10.3390/biology13050307
The basic biology of NK cells and its application in tumor immunotherapy.
Jiang P, Jing S, Sheng G, Jia F. · · 2024 · cited 17× · PMID 39221244 · DOI 10.3389/fimmu.2024.1420205
A novel anti-LAG-3/TIGIT bispecific antibody exhibits potent anti-tumor efficacy in mouse models as monotherapy or in combination with PD-1 antibody.
Dai T, Sun H, Liban T, Vicente-Suarez I, et al · · 2024 · cited 14× · PMID 38724599 · DOI 10.1038/s41598-024-61477-6
STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non-Small Cell Lung Cancer With No Actionable Gene Alterations.
Rodriguez-Abreu D, Bosch-Barrera J, Gray JE, Ahn MJ, et al · · 2024 · cited 10× · PMID 38310035 · DOI 10.1016/j.cllc.2023.12.010

Verify or expand the search:

Other trials of Zimberelimab

Trials testing the same drug.

NCT07397611 — Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC · Phase 2 · recruiting
NCT07283848 — Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma · Phase 2 · withdrawn
NCT06431633 — Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously · Phase 3 · recruiting
NCT06759649 — A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies · Phase 1 · recruiting
NCT06155396 — A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard T · Phase 2 · recruiting

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05502237 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 28 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05502237.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing