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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 5, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.