Clinical trial
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Name
CA209-227
Description
The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.
Trial arms
Trial start
2015-08-05
Estimated PCD
2024-08-29
Trial end
2024-08-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Nivolumab
Arms:
Arm A: Nivolumab, Arm B: Nivolumab + Ipilimumab, Arm C: Nivolumab + Platinum doublet chemotherapy
Other names:
Opdivo
Ipilimumab
Arms:
Arm B: Nivolumab + Ipilimumab
Other names:
Yervoy
Carboplatin
Arms:
Arm C: Nivolumab + Platinum doublet chemotherapy, Arm D: Platinum doublet chemotherapy
Cisplatin
Arms:
Arm C: Nivolumab + Platinum doublet chemotherapy, Arm D: Platinum doublet chemotherapy
Gemcitabine
Arms:
Arm C: Nivolumab + Platinum doublet chemotherapy, Arm D: Platinum doublet chemotherapy
Pemetrexed
Arms:
Arm C: Nivolumab + Platinum doublet chemotherapy, Arm D: Platinum doublet chemotherapy
Paclitaxel
Arms:
Arm C: Nivolumab + Platinum doublet chemotherapy, Arm D: Platinum doublet chemotherapy
Size
2748
Primary endpoint
Overall survival (OS)
approximately 48 months
Progression-free Survival (PFS) as determined by blinded independent central review (BICR)
approximately 40 months
Eligibility criteria
Inclusion Criteria:
* Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
* Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
* Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
Exclusion Criteria:
* Subjects with untreated Central nervous system (CNS) metastases are excluded
* Subjects with an active, known or suspected autoimmune disease are excluded
* Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
Other protocol defined inclusion/exclusion criteria apply
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2748, 'type': 'ACTUAL'}}
Updated at
2024-01-08
1 organization
7 products
1 abstract
1 indication
Product
NivolumabProduct
IpilimumabOrganization
Bristol-Myers SquibbProduct
CisplatinProduct
PemetrexedProduct
GemcitabineProduct
PaclitaxelProduct
CarboplatinIndication
NSCLCAbstract
Correlation of the combination of CT-derived tumor texture and vessel tortuosity on survival outcomes for immunotherapy but not for chemotherapy in metastatic non-small cell lung cancer (mNSCLC): Results from a CheckMate227 (CM227) subset.Org: Atlanta Veterans Administration Medical Center,