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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00760929
First received: September 25, 2008
Last updated: February 23, 2015
Last verified: February 2015
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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: Placebo Drug: RG1507 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:
- Standard safety monitoring, ECG, glucose ; population pharmacokinetics; assessment of potential predictive and prognostic biomarkers. [ Time Frame: Throughout the trial ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 167 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00760929
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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: | 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: | February 23, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases |
Respiratory Tract Neoplasms Thoracic Neoplasms Erlotinib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on March 01, 2015