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

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Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

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).

Background information
Trial ID: 
NCT00153803
Other unique IDs: 
D-0410
Official title: 

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).

Detailed description: 

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.

Number to be enrolled: 
380 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
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

Study design: 
Treatment
Randomized
Placebo Control
Parallel Assignment
Efficacy Study
Interventions: 
Placebo
Erlotinib (Tarceva)
Study arms: 
Placebo Comparator: Matched Placebo
Experimental: Tarceva 150mg
Conditions treated: 
Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
NSCLC
Outcome measurements: 

Overall Survival [ Time Frame: survival ] [ Designated as safety issue: No ]

2 year survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Assess the serious adverse event profile for erlotinib [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Assess molecular targets as potential markers of efficacy [ Time Frame: optional 12 months ] [ Designated as safety issue: No ]

Funding
Funding types: 
OTHER
INDUSTRY
Sponsor: 
Genentech
Dartmouth-Hitchcock Medical Center
Sanofi-Aventis
Dates
Date the data was first received: 
Wed, 2005-09-07
Trial start date: 
Sun, 2005-05-01
Trial completion date: 
Sat, 2012-12-01
Trial last updated: 
Wed, 2009-05-20