A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.

An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Monotherapy.

This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Inclusion Criteria:

• male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
• currently receiving Tarceva monotherapy and having failed at least one standard chemotherapy regimens;
• prior response or stable disease 12 weeks from start of Tarceva;
• documented progressive disease at enrollment;
• measurable disease according to the RECIST criteria;
• ECOG performance status 0-2;
• life expectancy >12 weeks.

Exclusion Criteria:

• patients with active CNS lesions;
• prior treatment with agents acting via IGF-1R inhibition or EGFR targeting;
• administration with high doses of systemic corticosteroids;
• radiotherapy in the 4 weeks prior to study start;
• surgery or significant traumatic injury with in the last 2 weeks prior to study start.