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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).

Phase 3
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer, NSCLC

Thank you

Trial Information

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).

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

James R Rigas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

July 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer
  • Erlotinib
  • Tarceva
  • Web based
  • Stage III NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Franklin Square Hospital CenterBaltimore, Maryland  21237
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Nevada Cancer Research FoundationLas Vegas, Nevada  89109
Winthrop University HospitalMineola, New York  11501
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Alexian Brothers Hospital NetworkElk Grove Village, Illinois  60007
Joliet Hematology AssociatesJoliet, Illinois  60435
Investigative Clinical Research of Indiana LLCIndianapolis, Indiana  46254
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Fallon Clinic Hematology/ OncologyWorcester, Massachusetts  01608
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