This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
15mg iv on day 1 of each 3 week cycle
As prescribed
Unnamed facility
Tugun, Australia
Unnamed facility
Wollongong, Australia
Unnamed facility
Liège, Belgium
Unnamed facility
Ostrava, Czechia
Unnamed facility
Ústí nad Labem, Czechia
Unnamed facility
Bobigny, France
Unnamed facility
Marseille, France
Unnamed facility
Nantes, France
Unnamed facility
Székesfehérvár, Hungary
Unnamed facility
Szombathely, Hungary
...and 15 more locations
Rate of grade >=3 Avastin-related pulmonary hemorrhage
Time frame: After a maximum of 12 months treatment
Overall response, duration of response, progression-free survival.
Time frame: Event driven
AEs, laboratory parameters, coagulation parameters.
Time frame: Throughout study
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