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Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

NCT00976456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2016-03-10

Study results available
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Summary

Multi-center, open, randomized (parallel) and comparative phase III.

Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.

Arm A: Bevacizumab + pemetrexed

Arm B: Bevacizumab + pemetrexed + carboplatin

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Interventions

DRUG

Bevacizumab + Pemetrexed

Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks

DRUG

Bevacizumab + Pemetrexed + Carboplatin

Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • PD Dr. med. Wolfgang Schuette

    lead OTHER

Principal Investigators

  • Wolfgang Schuette, PhD MD. · Krankenhaus Martha-Maria Halle-Doelau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976456 on ClinicalTrials.gov