A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must have histologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC) (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology. * Participants must have no prior systemic anti-cancer treatment (including EGFR, ALK, ROS-1, BRAF, RET, and NTRK inhibitors) given as primary therapy for advanced or metastatic disease. * Participants with prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (whichever…
Interventions
- DrugNivolumab
Specified dose on specified days
- DrugIpilimumab
Specified dose on specified days
- DrugCarboplatin
Specified dose on specified days
- DrugPaclitaxel
Specified dose on specified days
- DrugPemetrexed
Specified dose on specified days
- DrugCisplatin
Specified dose on specified days
Locations (48)
- Alaska Oncology and HematologyAnchorage, Alaska
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- Local Institution - 0088Newport Beach, California
- Local Institution - 0063Boise, Idaho
- Saint Alphonsus Regional Medical CenterBoise, Idaho
- Beacon Cancer CarePost Falls, Idaho