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.
Prospective, randomized multi-center, open label phase II study 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. * Duration of treatment/patient: up to 1,5 years * Follow Up: ≈ 6 month * Planned number of patients: 220 treated patients (110 patients/arm)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
150 mg per os, given daily until tumor progression
15mg/kg i.v. on day 1 (three-week cycle) until tumor progression
1250 mg/2 i.v. on day 1 and day 8 (three-week cycle) until tumor progression for a maximum of 6 cycles
The main efficacy parameter is the progression free survival.
Time frame: Recruitment 1 year, Follow up 2 years
Overall survival
Time frame: Recruitment 1 year, Follow up 2 years
Quality of life
Time frame: Screening, prior to next treatment cycle, treatment day 126, end of therapy
Response rate
Time frame: Screening, prior to treatment cycle 3, prior to treatment clycle 5, treatment day 126, every 6 weeks after treatment day 126, end of therapy
Molecular investigations
Time frame: Screening, prior to treatment cycle 3
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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)
Klinikum Bayreuth GmbH
Bayreuth, Germany
Charite´ Mitte
Berlin, Germany
Gemeinschaftskrankenhaus Havelhöhe
Berlin, Germany
Helios Klinikum Emil v. Behring
Berlin, Germany
Augusta-Krankenanstalten
Bochum, Germany
Johanniter-Krankenhaus Bonn
Bonn, Germany
Forschungszentrum Borstel
Borstel, Germany
Malteser Krankenhaus St. Hildegardis
Cologne, Germany
St. Johannes Hospital
Duisburg, Germany
Städtisches Krankenhaus Frankfurt-Höchst
Frankfurt, Germany
...and 27 more locations