Lung Cancer Alchemist A081105

April 27, 2017

Sponsor: National Cancer Institute (NCI)

Number: Alchemist A081105

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III (Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) trial that studies how well Erlotinib Hydrochloride compared to placebo works in treating patients with stage IB-IIIA (Click here for lung cancer staging definitions) non-small cell lung cancer that has been completely removed by surgery. Erlotinib Hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who’s eligible:

Previously registered to Alchemist –screen Alliance A151216 (a different clinical trial), with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:

  • Patient registered to A151216 and the assessment performed centrally by the protocol specified laboratory.
  • By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay (testing). These patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results.
  • Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) ( within a patients DNA) are not eligible. Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105. The patient must have completely resected (surgically cut out) stage IB (>= 4 cm), II or IIIA non-squamous NSCLC (non-small cell lung cancer) with negative margins. Margins are determined by your pathologist when the pathologist looks at your tissue sample under a microscope.
  • Patients must be completely recovered from surgery at the time of randomization and standard post-operative therapy (if required). The minimum time requirement between date of surgery and randomization must be at least 28 days. The maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy (therapy given after surgery) was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, Hartford Hospital, Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office