Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy for Non-small Cell Lung Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Non-small Cell Lung Cancer+2 More
Pemetrexed - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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 progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.
Eligible Conditions
- Non-small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Up to 58 Months
Month 58
Time to First Symptom Deterioration in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
Month 58
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 31 months
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Up to 58 Months
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Up to 58 months
Overall Survival (OS)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Pembrolizumab (PEMBRO) + Chemotherapy
1 of 3
Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy
1 of 3
Zimberelimab (ZIM) + Chemotherapy
1 of 3
Active Control
Experimental Treatment
720 Total Participants · 3 Treatment Groups
Primary Treatment: Zimberelimab (ZIM) +Domvanalimab (DOM) + Chemotherapy · No Placebo Group · Phase 3
Zimberelimab (ZIM) +Domvanalimab (DOM) + ChemotherapyExperimental Group · 7 Interventions: Pemetrexed, Nab-paclitaxel, Domvanalimab, Carboplatin, Cisplatin, Paclitaxel, Zimberelimab · Intervention Types: Drug, Drug, Biological, Drug, Drug, Drug, Biological
Zimberelimab (ZIM) + ChemotherapyExperimental Group · 6 Interventions: Pemetrexed, Nab-paclitaxel, Carboplatin, Cisplatin, Paclitaxel, Zimberelimab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Biological
Pembrolizumab (PEMBRO) + ChemotherapyActiveComparator Group · 6 Interventions: Pemetrexed, Nab-paclitaxel, Carboplatin, Pembrolizumab, Cisplatin, Paclitaxel · Intervention Types: Drug, Drug, Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5050
Nab-paclitaxel
2014
Completed Phase 3
~1680
Carboplatin
2014
Completed Phase 3
~7280
Cisplatin
2013
Completed Phase 3
~2700
Paclitaxel
2011
Completed Phase 4
~6620
Zimberelimab
2018
Completed Phase 1
~50
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 58 months
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,006 Previous Clinical Trials
652,669 Total Patients Enrolled
3 Trials studying Non-small Cell Lung Cancer
915 Patients Enrolled for Non-small Cell Lung Cancer
Arcus Biosciences, Inc.Industry Sponsor
29 Previous Clinical Trials
4,579 Total Patients Enrolled
2 Trials studying Non-small Cell Lung Cancer
78 Patients Enrolled for Non-small Cell Lung Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
316 Previous Clinical Trials
178,245 Total Patients Enrolled
3 Trials studying Non-small Cell Lung Cancer
915 Patients Enrolled for Non-small Cell Lung Cancer
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a life expectancy of 3 months or more.
You have documented evidence of Stage IV NSCLC disease at the time of enrollment.
You have a documented negative test result for EGFR and ALK mutations.
You have not received prior systemic treatment for metastatic NSCLC.
You have measurable disease by CT or MRI as per RECIST v1.1 criteria by investigator assessment.
You have a performance status of 0 or 1.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments