Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemothe… (NCT05502237) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
United States1,021 participantsStarted 2022-10-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Life expectancy ≥ 3 months.
* Pathologically documented NSCLC that meets both of the criteria below:
* Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
* Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
* Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
* Have not received prior systemic treatment for metastatic NSCLC.
* Measurable disease per RECIST v1.1 criteria by investigator assessment.
* Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
* Have adequate organ functions.
Key Exclusion Criteria:
* Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
* Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
* Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
* Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
* Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
* Have an active autoimmune disease that required systemic treatment in past …
What they're measuring
1
Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (≥1%Tumor Cells) and in all Randomized Participants.