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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153803
First Posted: September 12, 2005
Last Update Posted: November 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sanofi
Genentech, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
September 7, 2005
September 12, 2005
November 13, 2014
May 2005
April 2014   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 12 months ]
Progression Free Survival
Complete list of historical versions of study NCT00153803 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: survival ]
  • 2 year survival [ Time Frame: 24 months ]
  • Assess the serious adverse event profile for erlotinib [ Time Frame: 18 months ]
  • Assess molecular targets as potential markers of efficacy [ Time Frame: optional 12 months ]
  • Overall Survival
  • 2 year survival
  • Assess the serious adverse event profile for erlotinib
  • Assess molecular targets as potential markers of efficacy
Not Provided
Not Provided
 
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
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).
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-three survival time for these patients.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Carcinoma, Non-Small-Cell Lung
  • Non-small Cell Lung Cancer
  • NSCLC
  • Drug: Erlotinib (tarceva)
    Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 5 years of therapy.
  • Drug: Placebo
    Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 5 years of therapy.
  • Experimental: 1
    Tarceva 150mg
    Intervention: Drug: Erlotinib (tarceva)
  • Placebo Comparator: 2
    Matched Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00153803
D-0410
Yes
Not Provided
Not Provided
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
  • Sanofi
  • Genentech, Inc.
Study Chair: James R Rigas, MD Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP