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). - Full Text View

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-Squamous 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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients with progression free survival (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:	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
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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;
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.

Contacts and Locations

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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP, Novello S, Eberhardt WE, Crino L, Habben K, Liu L, Jänne PA, Brownstein CM, Reck M. Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol. 2011 Dec 1;29(34):4574-80. doi: 10.1200/JCO.2011.36.6799. Epub 2011 Oct 24.


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:	September 1, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms 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

ClinicalTrials.gov processed this record on September 30, 2016