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).

Roche

Status and phase: Terminated; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]; Drug: RG1507; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760929

NO21160

2008-001736-12 (EudraCT Number)

Details and patient eligibility

About

This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. 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 <500 individuals.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
• patients must have failed at least one but no more than two standard chemotherapy regimens;
• measurable disease according to the RECIST criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status;
• life expectancy >12 weeks.

Exclusion criteria

• patients with active central nervous system (CNS) lesions;
• prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 4 patient groups, including a placebo group

Placebo for R1507 (16mg/kg iv)

Placebo Comparator group

Treatment:

Drug: erlotinib [Tarceva]

Drug: Placebo

Drug: Placebo

Placebo for R1507 (9mg/kg iv)

Placebo Comparator group

Treatment:

Drug: erlotinib [Tarceva]

Drug: Placebo

Drug: Placebo

R1507 (16mg/kg iv)

Experimental group

Treatment:

Drug: RG1507

Drug: erlotinib [Tarceva]

Drug: RG1507

R1507 (9mg/kg iv)

Experimental group

Treatment:

Drug: RG1507

Drug: erlotinib [Tarceva]

Drug: RG1507