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Protocol No. A081105

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) (ALCHEMIST)

Objective 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.

Treatment Erlotinib is an investigational drug and will be taken once a day.

Description 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

Key Eligibility
  • 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 Lung

Therapies Involved Cytotoxic Chemotherapy; Other

Drugs Involved Not Applicable; OSI - 774 (erlotinib); Tarceva (erlotinib); erlotinib; placebo

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park; VA Hospital, Madison, WI