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.
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Progression Free Survival (PFS)
Outcome Description:
The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO21746
NCT ID:
NCT00773383
Start Date:
November 2008
Completion Date:
February 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina |
