NCTN: 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) (S1400I)
Study ID: S1400I
NCT Number: NCT02785952
SWOG Cancer Research Network
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: 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) (S1400I)
Trial Description: This 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.
Clinical data presented in the following publication(s):
- PMID 34264316
Disease type(s): Lung, Mediastinal and Pleural Neoplasm - Non-Small Cell Lung Cancer
Clinical Dataset(s) included:
- NCT02785952-D1 (PMID 34264316): There are three datasets (-D1 through -D3) for PMID 34264316, a primary publication for S1400I. This clinical dataset, NCT02785952-D1, contains patient-level data (one row per patient), including baseline, demographic, metastatic sites, and treatment information. It also contains assessment, survival, reasons for going off treatment, tumor mutational burden, PDL1 expression, and patient-reported outcome data.
- NCT02785952-D2 (PMID 34264316): There are three datasets (-D1 through -D3) for PMID 34264316, a primary publication for S1400I. This toxicity dataset, NCT02785952-D2, contains event-level data (one row per patient per adverse event experienced on trial).
- NCT02785952-D3 (PMID 34264316): There are three datasets (-D1 through -D3) for PMID 34264316, a primary publication for S1400I. This dataset, NCT02785952-D3, contains biomarker data (one row per patient per gene alteration).
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Clinical Trial
- Archive: The database of Genotypes and Phenotypes (dbGaP)