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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760929
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Placebo Drug: RG1507 Drug: erlotinib [Tarceva] Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo for R1507 (16mg/kg iv) Drug: Placebo
iv 16mg/kg every 3 weeks
Drug: erlotinib [Tarceva]
150mg oral daily
Placebo Comparator: Placebo for R1507 (9mg/kg iv) Drug: Placebo
iv 9mg/kg weekly
Drug: erlotinib [Tarceva]
150mg oral daily
Experimental: R1507 (16mg/kg iv) Drug: RG1507
iv 16mg/kg every 3 weeks
Drug: erlotinib [Tarceva]
150mg oral daily
Experimental: R1507 (9mg/kg iv) Drug: RG1507
iv 9mg/kg weekly
Drug: erlotinib [Tarceva]
150mg oral daily

Primary Outcome Measures :
  1. Proportion of patients with progression free survival (PFS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760929

  Show 71 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00760929     History of Changes
Other Study ID Numbers: NO21160
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs