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.

Part of paid clinical trials in Santa Monica, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT00773383
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Oct 16, 2008
Start date
Nov 30, 2008
Status verified
Jun 2013
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With Progression Free Survival (PFS) [ Time Frame: 12 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
-Santa MonicaCalifornia90404-
-MiamiFlorida33101-
-BostonMassachusetts02114-
-BostonMassachusetts02115-
-BostonMassachusetts02215-
-HickoryNorth Carolina28602-

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By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease

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