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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
2017-08-31
NCT00946712Uploaded 06-05-2021
Access via NCI by Request
PDS UID: nci-data-470
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)
Provider Information
Provider Data DescriptionThere are three data submissions associated with PMID 29169877: NCT00946712-D1 , -D2, and -D3. This clinical dataset, NCT00946712-D1, will allow users to reproduce the results reported in the Lancet Oncology (Herbst et al., Lancet Oncology, 2018). This dataset contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information. It also contains assessment data.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsRecurrent Large Cell Lung Carcinoma
Recurrent Lung Adenocarcinoma
Recurrent Squamous Cell Lung Carcinoma
Stage IV Large Cell Lung Carcinoma
Stage IV Lung Adenocarcinoma
Stage IV Squamous Cell Lung Carcinoma
Intervention TypeBiological: Bevacizumab
Drug: Carboplatin
Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug(s)Drug: Carboplatin
Drug: Paclitaxel
Total Enrolled1333
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (chemo +/- bevacizumab) - Experimental
Arm II (chemo, cetuximab, +/- bevacizumab) - Experimental
Secondary IDNCI-2009-01664
PubMed (PMID)34753703
29169877
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Mexico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00946712-D1
Data DictionaryNCT00946712-D1-Data-Dictionary_5.pdf
DATANCT00946712-D1-Dataset_5.csv
OTHERREADME.pdf
Files: NCT00946712-D2
Data DictionaryNCT00946712-D2-Data-Dictionary_4.pdf
DATANCT00946712-D2-Dataset_5.csv
OTHERREADME.pdf
Files: NCT00946712-D3
Data DictionaryNCT00946712-D3-Data-Dictionary_2.pdf
DATANCT00946712-D3-Dataset_3.csv
OTHERREADME.pdf
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