This single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is \<3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
7.5mg/kg every 3 weeks for 3 cycles (cohort 1) or 15mg/kg every 3 weeks for 3 cycles (cohort 2). Preferred dose every 3 weeks for 9 cycles (cohort 3).
80mg/m2 iv every 3 weeks for 3 cycles
100mg/m2 iv for 3 consecutive days, every 3 weeks for 3 cycles
Unnamed facility
Amsterdam, Netherlands
Unnamed facility
Groningen, Netherlands
Unnamed facility
Maastricht, Netherlands
Unnamed facility
Aberdeen, United Kingdom
Unnamed facility
Manchester, United Kingdom
Dose limiting toxicity
Time frame: Throughout Study
AEs, laboratory parameters
Time frame: Throughout Study
Tumor response
Time frame: Throughout Study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.