A phase II study of Pazopanib and pemetrexed in advanced NSCLC
Research type
Research Study
Full title
An open-label, multicentre, randomised phase II study of pazopanib in combination with pemetrexed in first-line treatment of subjects with predominantly non-squamous cell stage IIIBwet/IV non-small cell lung cancer.
IRAS ID
25421
Sponsor organisation
GlaxoSmithKline Ltd
Eudract number
2008-002144-42
Clinicaltrials.gov Identifier
Research summary
This is an open-label, multicentre, randomised Phase II study of pazopanib in combination with pemetrexed in first-line treatment of subjects with predominantly non-squamous cell Stage IIIBwet (with histologically or cytologically confirmed malignant pleural effusion) or Stage IV non-small cell lung cancer (NSCLC). The study is designed to evaluate the efficacy, safety, and tolerability of pazopanib administered orally (by mouth) once daily in combination with pemetrexed administered by intravenous (IV) infusion once every 3 weeks in this patient population.A standard of care treatment (cisplatin and pemetrexed administered IV once every 3 weeks) will be used to provide reference data for comparison with pazopanib and pemetrexed. All subjects will receive vitamin supplementation and dexamethasone prophylaxis (to prevent side effects) before receiving pemetrexed. The duration of cisplatin and/or pemetrexed treatment will be 4 or 6 cycles (defined according to hospital guidelines). Pazopanib will be administered orally (by mouth) once daily until disease progression, unacceptable toxicities, or death.The study will be conducted in approximately 25 centres (4 centres in the UK). A total of approximately 150 subjects will be enroled and randomised in a 2:1 ratio; 100 subjects will be assigned to Arm 1 (pazopanib and pemetrexed) and 50 subjects to Arm 2 (cisplatin and Pemetrexed).Patients that progress in arm 2 will have the opportunity to receive pazopanib if deemed appropriate by the investigator. The enrolment period will be approximately 12 months with a follow-up time of at least 6 months for primary analysis.
REC name
London - South East Research Ethics Committee
REC reference
09/H1102/85
Date of REC Opinion
22 Sep 2009
REC opinion
Further Information Favourable Opinion