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).
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | November 2008 |
| End Date: | June 2010 |
A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy
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.
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.
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.
We found this trial at
15
sites
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