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NCTN: 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) (E1505)

Study ID: E1505

NCT Number: NCT00324805

ECOG-ACRIN Cancer Research Group

Submitted in collaboration with the NCTN/NCORP Data Archive

Trial Title: NCTN: 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) (E1505)

Trial Description: This 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.

Clinical data presented in the following publication(s):

• PMID 29129443

Disease type(s): Lung, Mediastinal and Pleural Neoplasm - Non-Small Cell Lung Cancer

Clinical dataset(s) included:

• NCT00324805-D1 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D1, contains baseline characteristics, stratification factors, treatment, resection type, site of recurrence, and efficacy data.

• NCT00324805-D2 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D2, contains grade 2 toxicity data presented in Table 2 of the manuscript.

• NCT00324805-D3 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D3, contains grades 3-5 toxicity data presented in Table 3 of the manuscript.

• NCT00324805-D4 (PMID 29129443): There are four different datasets for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D4, contains worst grade toxicity information and 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.

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).