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Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) (ALCHEMIST)
The purpose of this study is to compare any good and bad effects patients may have when treated
with the standard treatment against patients who are treated with the standard treatment plus
erlotinib (an investigational drug). Patients in this research study have early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). We are trying to find out if this mutation could help us make decisions about which type of treatment is best for people with your type of cancer.
Erlotinib is an investigational drug and will be taken once a day.
This study has two study groups. You will be "randomized" into one of the study groups. Randomization means
that you are put into a group by chance. A computer program will place you in one of the study
groups. You will have an equal chance of being placed in either group. Group 1 will get the study drug called erlotinib. Group 2 will not receive erlotinib and will be followed by their doctor. Click here for more info
- Patients must be previously enrolled in study A151216 with the result of lung cancer harboring an EGRF exon 19 deletion or L858R mutation.
- Completely resected stage IB, II or IIIA non-squamous non small cell lung cancer with negative margins
Applicable Disease Sites
Cytotoxic Chemotherapy; Other
Not Applicable; OSI - 774 (erlotinib); Tarceva (erlotinib); erlotinib; placebo
Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park; VA Hospital, Madison, WI