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).

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT00760929
Phase
PHASE2
Status
Terminated

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    iv 9mg/kg weekly
  • Placebo — DRUG
    iv 16mg/kg every 3 weeks
  • RG1507 — DRUG
    iv 9mg/kg weekly
  • RG1507 — DRUG
    iv 16mg/kg every 3 weeks
  • erlotinib [Tarceva] — DRUG
    150mg oral daily

Study Details

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.

Key Dates

First listed
Sep 26, 2008
Start date
Nov 10, 2008
Status verified
Dec 2020
Primary completion
Jun 25, 2010
Completion
Jun 25, 2010

Study Design

Enrollment
171 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo for R1507 (16mg/kg iv)
  • Placebo Comparator: Placebo for R1507 (9mg/kg iv)
  • Experimental: R1507 (16mg/kg iv)
  • Experimental: R1507 (9mg/kg iv)

Primary Outcome Measure

Number of Participants With Progression Free Survival (PFS) [ Time Frame: 12 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
Tower Cancer Research FoundationBeverly HillsCalifornia90211-
Florida Cancer Inst.New Port RicheyFlorida34655-
Emory Univ Winship Cancer InstAtlantaGeorgia30322-
University of Chicago Medical Center; Dept. of Medicine/Section of NephrologyChicagoIllinois60637-
North Shore University Health SystemGlenviewIllinois60026-
Joliet Oncology Hematology Associates, Ltd.JolietIllinois60435-
St. Joseph Medical CenterTowsonMaryland21204-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer Inst.BostonMassachusetts02115-
Massachusetts General Hospital.BostonMassachusetts02114-
Hackensack University Medical CenterHackensackNew Jersey07601-
Carolina Oncology Specialists, PA - HickoryHickoryNorth Carolina28602-
Chattanooga Oncology and Hematology Associates, PCChattanoogaTennessee37404-
Sarah Cannon Research Inst.NashvilleTennessee37203-
Virginia Cancer InstituteRichmondVirginia23226-

Find similar trials in Beverly Hills, CA

By research site
Tower Cancer Research Foundation· Beverly Hills, CAFlorida Cancer Inst.· New Port Richey, FLEmory Univ Winship Cancer Inst· Atlanta, GAUniversity of Chicago Medical Center; Dept. of Medicine/Section of Nephrology· Chicago, ILNorth Shore University Health System· Glenview, ILJoliet Oncology Hematology Associates, Ltd.· Joliet, IL

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