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

Sponsor
Aktion Bronchialkarzinom e.V.
Study ID
NCT00536640
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    150 mg per os, given daily until tumor progression
  • Bevacizumab — DRUG
    15mg/kg i.v. on day 1 (three-week cycle) until tumor progression
  • Gemcitabine — DRUG
    1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles
  • Cisplatin — DRUG
    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)

Study Details

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.

Key Dates

First listed
Sep 28, 2007
Start date
Nov 30, 2007
Status verified
Jun 2013
Primary completion
Aug 31, 2011
Completion
May 31, 2012

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Erlotinib, Bevacizumab)
  • Active Comparator: Arm B (Gemcitabine, Cisplatin, Bevacizumab)

Primary Outcome Measure

The main efficacy parameter is the progression free survival. [ Time Frame: Recruitment 1 year, Follow up 2 years ]

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