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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
December 2019
NCT02785952Uploaded 03-25-2023
Access via NCI by Request
PDS UID: nci-data-510
A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)
Provider Information
Provider Data DescriptionThere are three datasets for PMID 34264316 containing the results reported in JAMA Oncology (Gettinger et al., JAMA Oncology, 2021). This clinical dataset, NCT02785952-D1, contains patient-level data (one row per patient), including baseline, demographic, and treatment information. It also contains assessment data.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.
ConditionsRecurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma AJCC v7
Intervention TypeBiological: Ipilimumab
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug(s)N/A
Total Enrolled275
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (nivolumab, ipilimumab) - Experimental
Arm II (nivolumab) - Active Comparator
Secondary IDNCI-2016-00050
PubMed (PMID)34264316
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files: NCT02785952-D1
Data DictionaryNCT02785952-D1-Data-Dictionary_3.pdf
DATANCT02785952-D1-Dataset_4.csv
OTHERREADME.pdf
Files: NCT02785952-D2
Data DictionaryNCT02785952-D2-Data-Dictionary_2.pdf
DATANCT02785952-D2-Dataset_3.csv
OTHERREADME.pdf
Files: NCT02785952-D3
Data DictionaryNCT02785952-D3-Data-Dictionary_1.pdf
DATANCT02785952-D3-Dataset_1.csv
OTHERREADME.pdf
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