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Type(s) of Cancer
Lung (Non-Small Cell)

Study Phase
Phase 3

Study Completion Date
October 2015

NCT00324805Uploaded 04-24-2019

Access via NCI by Request

PDS UID - nci-data-394

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 Information

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

DOIN/A

CDISC StandardNon-SDTM

Study ArmsUndefined

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.

ConditionsStage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Intervention TypeBiological: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
Other: Questionnaire Administration
Drug: Vinorelbine Tartrate

Drug(s)Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Pemetrexed Disodium
Drug: Vinorelbine Tartrate

Total Enrolled1501

RandomizationRandomized

Blinding MethodNone (Open Label)

Arms InterventionArm I (chemotherapy) - Active Comparator
Arm II (chemotherapy, bevacizumab) - Experimental

Secondary IDNCI-2009-00509

PubMed (PMID)29129443

Collaborator(s)Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group

Region(s)United States
Canada
Ireland
Peru
South Africa

Age RangeMinimum Age: 18 Years
Maximum Age: NA

Files: NCT00324805-D1

Data DictionaryNCT00324805-D1-Data-Dictionary.pdf

DATANCT00324805-D1-Dataset.csv

OTHERREADME.pdf

Files: NCT00324805-D2

Data DictionaryNCT00324805-D2-Data-Dictionary.pdf

DATANCT00324805-D2-Dataset.csv

OTHERREADME.pdf

Files: NCT00324805-D3

Data DictionaryNCT00324805-D3-Data-Dictionary.pdf

DATANCT00324805-D3-Dataset.csv

OTHERREADME.pdf

Files: NCT00324805-D4

Data DictionaryNCT00324805-D4-Data-Dictionary.pdf

DATANCT00324805-D4-Dataset.csv

OTHERREADME.pdf