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Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabine/Cisplatin Plus Bevacizumab

NCT00536640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2013-06-12

No results posted yet for this study

Summary

This study wants to determine the activity of a non chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non Small Lung Cancer.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Erlotinib

150 mg per os, given daily until tumor progression

DRUG

Bevacizumab

15mg/kg i.v. on day 1 (three-week cycle) until tumor progression

DRUG

Gemcitabine

1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles

DRUG

Cisplatin

80 mg/m2 i.v. on day 1 (three-week cycle) until tumor progression for a maximum of 6 cycles. (The administration of 40 mg/2 Cisplatin on day 1 and day 8 is also possible)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Aktion Bronchialkarzinom e.V.

    lead OTHER

Principal Investigators

  • Prof. Dr. Martin Wolf, MD · Aktion Bronchialkarzinom e.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-08-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT00536640 on ClinicalTrials.gov