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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
January 2019
NCT01107626Uploaded 03-15-2023
Access via NCI by Request
PDS UID: nci-data-508
Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Provider Information
Provider Data DescriptionThere are two different submissions for PMID 31361535 from trial E5508. This dataset, NCT01107626-D1, contains baseline, treatment, and efficacy data. Dataset NCT01107626-D2 contains toxicity data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
ConditionsLung Cancer
Intervention TypeDrug: Paclitaxel
Drug: Carboplatin
Biological: Bevacizumab
Drug: Pemetrexed Disodium Heptahydrate
Drug(s)Drug: Paclitaxel
Drug: Carboplatin
Drug: Pemetrexed Disodium Heptahydrate
Total Enrolled1516
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (Induction then Maintenance with Bevacizumab) - Experimental
Arm B (Induction then Maintenance with Pemetrexed) - Experimental
Arm C (Induction then Maintenance with Bevacizumab & Pemetrexed) - Experimental
Secondary IDNCT01107626
PubMed (PMID)31361535
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Files: NCT01107626-D1
Data DictionaryNCT01107626-D1-Data-Dictionary_1.pdf
DATANCT01107626-D1-Dataset_6.csv
OTHERREADME.pdf
Files: NCT01107626-D2
Data DictionaryNCT01107626-D2-Data-Dictionary_1.pdf
DATANCT01107626-D2-Dataset_4.csv
OTHERREADME.pdf
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