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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients with PFS

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21160

NCT ID:

NCT00760929

Start Date:

November 2008

Completion Date:

September 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Nashville, Tennessee  37203-1632
McLean, Virginia  22101
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina