A phase II study is assessing the safety and efficacy of Sunitinib ( Sutent ) in patients with advanced non-small cell lung cancer ( NSCLC ) that had progressed following standard therapy.

“ This is the first clinical trial to evaluate Sunitinib alone in advanced lung cancer patients for whom prior therapy has failed,” said lead author Mark A. Socinski, at the University of North Carolina. “ Our findings suggest that Sunitinib may have a place in the treatment of lung cancer, alone or in combination with other agents.”

Sunitinib is an oral, multitargeted tyrosine kinase inhibitor targeting VEGFR, PDGFR, KIT, FLT3 and RET on tumor cells, tumor neovasculature and pericytes.

Sutent is already approved for the treatment of advanced kidney cancer and a rare form of sarcoma called gastrointestinal stromal tumor ( GIST ).
Other ongoing studies are evaluating the effectiveness of Sunitinib in combination with therapies that target lung cancer in other ways, such as Erlotinib ( Tarceva ).

In this study, 63 patients with NSCLC received 50 mg of Sunitinib daily for four weeks followed by two weeks off treatment.
Patients continued on treatment until their disease progressed.

Six patients ( 9.5% ) experienced partial responses ( 9.5% ). Stable disease has been observed in an additional 12 patients ( 19.0% ).

Grade 3-4 toxicities included fatigue/asthenia ( 21% ), nausea ( 7% ), vomiting ( 7% ), abdominal pain ( 7% ), and hypertension ( 5% ). Most toxicities were grade 1-2 and included asthenia/fatigue ( 68% ), anorexia ( 40% ), dyspnea ( 37% ), cough ( 35% ), nausea ( 33% ), mucositis ( 32% ), dysgeusia ( 25% ), diarrhea ( 21% ), vomiting ( 19% ), and constipation ( 19% ).

Two patients died from pulmonary hemorrhage, and one died from cerebral hemorrhage.

The trial is being extended to explore a continuous dosing strategy of Sunitinib at 37.5 mg/day.

Source: 42nd Annual Meeting – American Society of Clinical Oncology ( ASCO ), 2006


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