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 study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00760929
First received: September 25, 2008
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: RG1507
Drug: Placebo
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with PFS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Overall survival; objective response rate; time to response; time to progressive disease; duration of response. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Standard safety monitoring, ECG, glucose ; population pharmacokinetics; assessment of potential predictive and prognostic biomarkers. [ Time Frame: Throughout the trial ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
iv 9mg/kg weekly
Drug: erlotinib [Tarceva]
150mg oral daily
Placebo Comparator: 2 Drug: Placebo
iv 9mg/kg weekly
Drug: erlotinib [Tarceva]
150mg oral daily
Experimental: 3 Drug: RG1507
iv 16mg/kg every 3 weeks
Drug: erlotinib [Tarceva]
150mg oral daily
Placebo Comparator: 4 Drug: Placebo
iv 16mg/kg every 3 weeks
Drug: erlotinib [Tarceva]
150mg oral daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760929

  Hide Study Locations
Locations
United States, California
Beverly Hills, California, United States, 90211
United States, Florida
New Port Richey, Florida, United States, 34655
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60637
Evanston, Illinois, United States, 60201
Highland Park, Illinois, United States, 60035
Joliet, Illinois, United States, 60435
United States, Maryland
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
Boston, Massachusetts, United States, 02115
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Hickory, North Carolina, United States, 28602
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Nashville, Tennessee, United States, 37203
United States, Virginia
Richmond, Virginia, United States, 23230
Australia
Adelaide, Australia, 5065
Bedford Park, Australia, 5042
Frankston, Australia, 3199
Nedlands, Australia, 6009
St. Leonards, Australia, 2065
Belgium
Bruxelles, Belgium, 1090
Bruxelles, Belgium, 1200
Charleroi, Belgium, 6000
Edegem, Belgium, 2650
Herestraat 49, Belgium, 300
Liege, Belgium, 4000
Canada, Ontario
Oshawa, Ontario, Canada, L1G 2B9
France
La Tronche, France, 38700
Lyon, France, 69004
Paris, France, 75970
Paris, France, 75674
Paris, France, 75475
Paris, France, 75249
Saint Herblain, France, 44805
Toulouse, France, 31059
Germany
Bad Berka, Germany, 99437
Berlin, Germany, 14165
Essen, Germany, 45147
Grosshansdorf, Germany, 22927
Halle (saale), Germany, D-06120
Hamburg, Germany, 21075
Heidelberg, Germany, 69126
Herne, Germany, 44625
Leverkusen, Germany, 51375
Mannheim, Germany, 68167
München, Germany, 80336
Oldenburg, Germany, 26121
Ireland
Dublin, Ireland, 8
Italy
Genova, Italy, 16132
Milano, Italy, 20162
Orbassano, Italy, 10043
Perugia, Italy, 6156
Reggio Emilia, Italy, 42100
Poland
Gdansk, Poland, 80-211
Krakow, Poland, 31-531
Poznan, Poland, 60-569
Szczecin, Poland, 70-891
Warszawa, Poland, 02-097
Warszawa, Poland, 02-781
Spain
Barakaldo, Spain, 48903
Barcelona, Spain, 08036
Barcelona, Spain, 08041
La Coruna, Spain, 15006
Madrid, Spain, 28222
Malaga, Spain, 29010
United Kingdom
Guildford, United Kingdom, GU2 5XX
London, United Kingdom, SE1 9RT
Manchester, United Kingdom, M23 9LT
Newcastle Upon Tyne, United Kingdom, NE4 6BE
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00760929     History of Changes
Other Study ID Numbers: NO21160, 2008-001736-12
Study First Received: September 25, 2008
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014