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A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (? 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)
Provider Data DescriptionThere are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D1, contains baseline, treatment, and efficacy data. Dataset NCT00324805-D2 contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D3 contains toxicity data for duplicating the results in Table 3 of the manuscript. Dataset NCT00324805-D4 can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset1501
# of Patients Control749
# of Patients Experimental749
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.