An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer

An Exploratory Study on Anti-tumour Activity of Orally Administered RO4929097, a Gamma-secretase Inhibitor, as a Single Agent in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer (NSCLC).

This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is <50.

Inclusion Criteria:

• adult patients, >/= 18 years of age
• stage IIIB/IV recurrent or refractory non-small cell lung cancer
• at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy)
• ECOG performance status 0-2
• adequate liver, renal and bone marrow function

Exclusion Criteria:

• prior chemotherapy or radiotherapy </= 4 weeks before first dose of study drug
• history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma
• history of CNS metastases or leptomeningeal metastases, except for clinically stable disease
• serious cardiovascular illness