NCTN: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (S0819)
Study ID: S0819
NCT Number: NCT00946712
SWOG Cancer Research Network
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) (S0819)
Trial Description: This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.
Clinical data presented in the following publication(s):
- PMID 29169877
Disease type(s): Lung, Mediastinal and Pleural Neoplasm - Non-Small Cell Lung Cancer
Clinical Dataset(s) included:
- NCT00946712-D1 (PMID 29169877): There are three datasets associated with PMID 29169877: NCT00946712-D1, -D2, and -D3. This clinical dataset, NCT00946712-D1, contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, EGFR FISH results, protocol deviations, and baseline information. It also contains response and survival data.
- NCT00946712-D2 (PMID 29169877): There are three datasets associated with PMID 29169877: NCT00946712-D1, -D2, and -D3. This toxicity dataset, NCT00946712-D2, contains event-level information (one row per patient per adverse event experienced on trial).
- NCT00946712-D3 (PMID 29169877): There are three datasets associated with PMID 29169877: NCT00946712-D1, -D2, and -D3. This dataset, NCT00946712-D3, contains specific reasons for off treatment due to toxicity.
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: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)