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Trial information
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: Not yet recruiting
Protocol number: NO21160
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double blind study to determine the effect of two dose schedules of R1507 or placebo, both in combination with Tarceva (erlotinib), on progression-free survival in patients with advanced non-small cell lung cancer with disease progression after first or second line therapy.
Brief summary: 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. Target sample size is
150.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: R1507
Primary outcome: 1. Proportion of patients with PFS Time frame: 12 weeks
Key secondary outcomes: 1. Efficacy: Overall survival; objective response rate; time to response; time to progressive disease; duration of response. Time frame: Event driven
2. Standard safety monitoring, ECG, glucose ; population pharmacokinetics; assessment of potential predictive and prognostic biomarkers. Time frame: Throughout the trial
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;
- ECOG performance status;
- life expectancy >12 weeks.
Exclusion criteria: - patients with active CNS lesions;
- prior treatment with agents acting via IGF-1R inhibition or 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2008
Trial registration date: 09/25/2008
Date last updated: 11/21/2008
Link to trial result
This trial will be conducted at the following locations:Australia - Adelaide
- Fitzroy
- Frankston
- Heidelberg
- Melbourne
- Nedlands
- Parkville
- Perth
- St. Leonards
- Sydney
- Waratah
Austria - Graz
- Innsbruck
- Klagenfurt
- Wien
Belgium - Bruxelles
- Charleroi
- Edegem
- Herestraat 49
- Liege
Canada - Calgary, AB
- Edmonton, AB
- Victoria, BC
- London, ON
- Oshawa, ON
- Ottawa, ON
- Toronto, ON
- Greenfield Park, QC
- Laval, QC
- Montreal, QC
- Quebec City, QC
- Sainte-Foy, QC
France - Bayonne
- Belfort
- Bobigny
- Brest
- Clermont-Ferrand
- Dijon
- Grenoble
- Le Mans
- Lille
- Limoges
- Lyon
- Marseille
- Montbeliard
- Montpellier
- Nantes
- Paris
- Pau
- Pierre Benite
- Rennes
- Rouen
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
- Villejuif
Germany - Bad Berka
- Berlin
- Essen
- Grosshansdorf
- Halle
- Hamburg
- Heidelberg
- Herne
- Köln
- Leverkusen
- Mainz
- Mannheim
- München
- Oldenburg
Ireland Italy - Genova
- Milano
- Napoli
- Orbassano
- Parma
- Perugia
- Reggio Emilia
Netherlands - Amsterdam
- Arnhem
- Nijmegen
Poland - Gdansk
- Krakow
- Lodz
- Poznan
- Szczecin
- Warszawa
Spain - Barakaldo
- Barcelona
- La Coruna
- Madrid
- Malaga
- Oviedo
- Santander
- Valencia
United Kingdom - Birmingham
- Chelsmford
- Guildford
- Leicester
- London
- Manchester
- Newcastle upon Tyne
- Sutton
- Wolverhampton
United States - Beverly Hills, CA
- Sacramento, CA
- Torrington, CT
- New Port Richey , FL
- Atlanta, GA
- Chicago, IL
- Joliet, IL
- Baltimore, MD
- Towson, MD
- Boston, MA
- Omaha, NE
- Las Vegas, NV
- Hackensack, NJ
- New York, NY
- Chapel Hill, NC
- Durham, NC
- Hickory , NC
- Columbus, OH
- Bethlehem, PA
- Collierville, TN
- Knoxville, TN
- Memphis , TN
- Nashville, TN
- Houston, TX
- Seattle, WA
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