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Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT00153803

CompletedPhase 3

Sponsor: Dartmouth-Hitchcock Medical Center

Conditions: Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer, NSCLC

Interventions: Erlotinib (tarceva), Placebo

Countries: United States

This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
* No evidence of metastatic disease
* No prior treatment
* Adequate organ function
* Adequate pulmonary function (FEV \>= 1.0L or predicted FEV \>0.8L)

Exclusion Criteria:

* Metastasis
* Prior treatment
* Malignant pleural or pericardial effusion
* Peripheral neuropathy \>= grade 2
Locations (65)
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Fort Smith, Arkansas, United States
  • Hot Springs, Arkansas, United States
  • Berkeley, California, United States
  • Redding, California, United States
  • Sacramento, California, United States
  • Hartford, Connecticut, United States
  • Middletown, Connecticut, United States
  • New Britain, Connecticut, United States
  • New London, Connecticut, United States
  • Norwalk, Connecticut, United States
  • Stamford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Brooksville, Florida, United States
  • Fort Myers, Florida, United States
  • Fort Myers, Florida, United States
  • Jupiter, Florida, United States
  • Lake City, Florida, United States
  • New Port Richey, Florida, United States
  • Orange City, Florida, United States
  • Orlando, Florida, United States
  • Tamarac, Florida, United States
  • West Palm Beach, Florida, United States
  • Elk Grove Village, Illinois, United States
  • Joliet, Illinois, United States
  • Indianapolis, Indiana, United States
  • Kokomo, Indiana, United States
  • Ames, Iowa, United States
  • Hazard, Kentucky, United States
  • + 35 more on CT.gov