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

Completed · Phase 3 · Has a placebo group

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

In brief

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).

Key facts

Study ID

NCT00153803

Run by

Dartmouth-Hitchcock Medical Center

People needed

245

Starts

2005-05-01

Expected to finish

2014-04-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Metastasis
• Prior treatment
• Malignant pleural or pericardial effusion
• Peripheral neuropathy >= grade 2

Where it is running

• Oncology Specialties, P.C. — Huntsville, Alabama, United States
• Cooper Clinic — Fort Smith, Arkansas, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• Northstate Cancer Speciality — Redding, California, United States
• Mercy General Hospital — Sacramento, California, United States
• St. Francis Hospital Cancer Center — Hartford, Connecticut, United States
• Connecticut Oncology Group — Middletown, Connecticut, United States
• George Bray Cancer Center/New Britain General Hospital — New Britain, Connecticut, United States
• Oncology and Hematology Associates, PC — New London, Connecticut, United States
• Whittingham Cancer Center at Norwalk Hospital — Norwalk, Connecticut, United States
• Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center — Stamford, Connecticut, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Pasco Hernando Oncology Associates — Brooksville, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Lee Cancer Clinic — Fort Myers, Florida, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• Cancer Care of North Florida — Lake City, Florida, United States
• Pasco/Hernando Oncology — New Port Richey, Florida, United States
• Mid Florida Oncology — Orange City, Florida, United States
• MD Anderson — Orlando, Florida, United States
• Oncology & Hematology Association of West Broward — Tamarac, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Alexian Brothers Hospital Network — Elk Grove Village, Illinois, United States
• Birmingham Hematology and Oncology Associates, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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