Zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy in patients with untreated metastatic non-small cell lung cancer
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2061230073
- Lead Sponsor
- Ali Nasermoaddeli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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 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
- Have mixed small-cell lung cancer 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method