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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).
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).

NCT00760929

TerminatedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Interventions: Placebo, Placebo, RG1507, RG1507, erlotinib [Tarceva]

Countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (57)
  • Beverly Hills, California, United States
  • New Port Richey, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Glenview, Illinois, United States
  • Joliet, Illinois, United States
  • Towson, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Hackensack, New Jersey, United States
  • Hickory, North Carolina, United States
  • Chattanooga, Tennessee, United States
  • Nashville, Tennessee, United States
  • Richmond, Virginia, United States
  • Adelaide, South Australia, Australia
  • Frankston, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Brussels, Belgium
  • Charleroi, Belgium
  • Edegem, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Oshawa, Ontario, Canada
  • La Tronche, France
  • Lyon, France
  • Paris, France
  • Paris, France
  • Toulouse, France
  • Bad Berka, Germany
  • + 27 more on CT.gov