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).
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.
Checked against the public recordLast updated Jan 5, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Placebo; Drug: Placebo; Drug: RG1507; Drug: RG1507; Drug: erlotinib [Tarceva]
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Tower Cancer Research FoundationBeverly Hills, California
- Florida Cancer Inst.New Port Richey, Florida
- Emory Univ Winship Cancer InstAtlanta, Georgia
- University of Chicago Medical Center; Dept. of Medicine/Section of NephrologyChicago, Illinois
- North Shore University Health SystemGlenview, Illinois
- Joliet Oncology Hematology Associates, Ltd.Joliet, Illinois
- St. Joseph Medical CenterTowson, Maryland
- Massachusetts General Hospital.Boston, Massachusetts
- Dana Farber Cancer Inst.Boston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Hackensack University Medical CenterHackensack, New Jersey
- Carolina Oncology Specialists, PA - HickoryHickory, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 5, 2021. Always confirm current availability with the study team.