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

  Show 71 Study Locations
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 24, 2014