Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Pemetrexed

Pembrolizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.

Participants will receive zimberelimab monotherapy by IV infusion.

Participants will receive zimberelimab in combination with AB154 by IV infusion.

Participants will receive domvanalimab in combination with zimberelimab by IV infusion.

Participants will receive pembrolizumab by IV infusion.

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Domvanalimab

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Zimberelimab

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor

Medical Director

This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.

Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer

A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Arm D vs. Arm E - PFS as assessed by RECIST v1.1 by blinded independent central review

Arm D vs. Arm E - ORR as assessed by RECIST v1.1 by blinded independent central review

Gilead Sciences

Arcus Biosciences, Inc.

Immunomodulating Agents

Participants will receive zimberelimab as an intravenous (IV) infusion.

Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.

Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion

Etrumadenant is an A2aR and A2bR antagonist

Etrumadenant

This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.

This is an open-label phase 2 study in participants with non-small cell lung cancer which will assess the safety, efficacy and tolerability of zimberelimab as monotherapy and in combination with other immunotherapeutics across multiple treatment arms.

Approximately 150 participants will be randomized to 1 of 3 treatment arms: 1) zimberelimab, 2) zimberelimab + domvanalimab (anti-TIGIT antibody), 3) zimberelimab + domvanalimab + etrumadenant (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + domvanalimab + etrumadenant.

The primary objective of this clinical study is to evaluate the efficacy of each combination therapy by assessing: 1) objective response rate (ORR) of participants with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and 2) progression free survival (PFS).

Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer

The number and percentage of participants that experience TEAE

Serum concentration of zimberelimab as determined by validated assays

Serum concentration of domvanalimab as determined by validated assays

Serum concentration of etrumadenant as determined by validated assays

Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab

Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer	NCT04736173	Non Small Cell ... Nonsquamous Non... Squamous Non Sm... Lung Cancer	Domvanalimab Zimberelimab Carboplatin Paclitaxel Pemetrexed Pembrolizumab	18 Years -	Arcus Biosciences, Inc.
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer	NCT04262856	Non Small Cell ... Nonsquamous Non... Squamous Non Sm... Lung Cancer	Domvanalimab Etrumadenant Zimberelimab	18 Years -	Arcus Biosciences, Inc.

Spots Global Cancer Trial Database for nonsquamous non small cell lung cancer