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).
Public ClinicalTrials.gov record NCT00760929. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00760929
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 171 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 9, 2008
- Primary completion
- Jun 24, 2010
- Completion
- Jun 24, 2010
- Last update posted
- Jan 4, 2021
2008 – 2010
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tower Cancer Research Foundation | Beverly Hills | California | 90211 | — |
| Florida Cancer Inst. | New Port Richey | Florida | 34655 | — |
| Emory Univ Winship Cancer Inst | Atlanta | Georgia | 30322 | — |
| University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology | Chicago | Illinois | 60637 | — |
| North Shore University Health System | Glenview | Illinois | 60026 | — |
| Joliet Oncology Hematology Associates, Ltd. | Joliet | Illinois | 60435 | — |
| St. Joseph Medical Center | Towson | Maryland | 21204 | — |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | — |
| Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee | 37404 | — |
| Sarah Cannon Research Inst. | Nashville | Tennessee | 37203 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00760929, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 4, 2021 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00760929 live on ClinicalTrials.gov.