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

• 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 ]

• Overall Survival
• 2 year survival
• Assess the serious adverse event profile for erlotinib
• Assess molecular targets as potential markers of efficacy

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.

• 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

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

• Sanofi
• Genentech