Lung Cancer Clinical Trial
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
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.
Key Inclusion Criteria:
Life expectancy â‰¥ 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 known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved therapies (actionable genomic alteration).
Have not received prior systemic treatment for metastatic NSCLC.
Measurable disease by CT or MRI as 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 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Are receiving chronic systemic steroids.
Have significant third-space fluid retention
Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has had an allogenic tissue/solid organ transplant.
Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 96 Locations for this study
Glendale Arizona, 85304, United States
Santa Barbara California, 93105, United States
Whittier California, 90606, United States
Norwich Connecticut, 06360, United States
Lake City Florida, 32024, United States
Sarasota Florida, 34232, United States
Atlanta Georgia, 30318, United States
Peoria Illinois, 61615, United States
Asheville North Carolina, 28806, United States
Cincinnati Ohio, 45242, United States
Eugene Oregon, 97401, United States
Pittsburgh Pennsylvania, 15212, United States
Arlington Texas, 76012, United States
Austin Texas, 78745, United States
Dallas Texas, 75246, United States
Sherman Texas, 75090, United States
Arlington Virginia, 22205, United States
Blacksburg Virginia, 24060, United States
Vancouver Washington, 98684, United States
Capital , F5300, Argentina
Cardoba , X5008, Argentina
Cordoba , 5000, Argentina
Rosario , 2000, Argentina
Rosario , S2000, Argentina
Rosario , S2002, Argentina
Rosario , S2013, Argentina
San Miguel de TucumÃ¡n , 4000, Argentina
Viedma , 8500, Argentina
Klagenfurt Am Woerthersee , , Austria
Linz , 4020, Austria
Wien , A-114, Austria
Aalst , 9300, Belgium
Charleroi , 6000, Belgium
Mechelen , 2800, Belgium
Namur , 5000, Belgium
Fortaleza , 60430, Brazil
Porto Alegre , 90020, Brazil
Porto Alegre , 90610, Brazil
Sao Paulo , 03102, Brazil
Rimouski , G5L5T, Canada
Saint-JÃ©rÃ´me , J7Z 5, Canada
Providencia , 75000, Chile
Providencia , 75100, Chile
Puerto Montt , 55002, Chile
Santiago , 83311, Chile
Temuco , 48008, Chile
Vina del Mar , 25206, Chile
Chemnitz , 9116, Germany
Grosshansdorf , 22927, Germany
Halle , 06120, Germany
Hamburg , 21075, Germany
Hamburg , 22087, Germany
Karlsruhe , 76137, Germany
Kassel , 34125, Germany
Lubeck , 23538, Germany
Hong Kong , , Hong Kong
New Territories , , Hong Kong
Beer Seva , 84101, Israel
Jerusalem , 91031, Israel
Nahariya , , Israel
Petah Tiqva , 49100, Israel
Rehovot , 76100, Israel
Tel Aviv , 64239, Israel
Avellino , , Italy
Genova , 16132, Italy
Milano , 20132, Italy
Napoli , 80131, Italy
Pesaro , 61122, Italy
Piacenza , 29100, Italy
Rome , 00144, Italy
Treviglio , 24047, Italy
Breda , 4818 , Netherlands
Ede , 6716 , Netherlands
Harderwijk , 3844 , Netherlands
Tilburg , , Netherlands
Amadora , 27202, Portugal
Lisboa , , Portugal
Senhora da Hora , 4464-, Portugal
Singapore , 18877, Singapore
Singapore , 30843, Singapore
Barcelona , 08041, Spain
Barcelona , 8028, Spain
Barcelona , 8035, Spain
Barcelona , 8208, Spain
Cordoba , 14004, Spain
Girona , 17007, Spain
Jaen , 23007, Spain
Madrid , 28020, Spain
Madrid , 28027, Spain
Madrid , 28046, Spain
Majadahonda , 28222, Spain
Reus , 43204, Spain
Rincon de la Victoria , 29011, Spain
Sevilla , 41009, Spain
Seville , 41014, Spain
Valencia , 46009, Spain
Valencia , 46015, Spain
Valencia , 46015, Spain
Changhua City , 500-0, Taiwan
Kaohsiung City , 824, Taiwan
Kaohsiung , 807, Taiwan
Kaohsiung , 83301, Taiwan
Tainan , 70403, Taiwan
Tainan , , Taiwan
Taipei , 10002, Taiwan
Taoyuan City , 33305, Taiwan
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