Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo
works in treating patients with stage IB-IIIA 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.

Eligibility Criteria

Inclusion Criteria:

- Previously registered to A151216, 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:

1. Patient registered to A151216 and the assessment performed centrally by the
protocol specified laboratory

2. 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; 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) are not eligible

- Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK)
rearrangements will be registered to A081105

- Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative

- Complete recovery from surgery and standard post-operative therapy (if required);
patients must be completely recovered from surgery at the time of randomization; 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 was administered, 180 days if adjuvant chemotherapy
was administered, and 240 days if adjuvant chemotherapy and radiation therapy was

- No interstitial fibrosis or lung disease

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- No prior or concurrent malignancies within 5 years, except non-melanoma skin
carcinoma and in situ carcinomas

- Non-pregnant and non-lactating

- Granulocytes >= 1,500/ul

- Platelets >= 100,000/ul

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN

- Serum creatinine =< 1.5 x ULN

Principal Investigator

Chao H. Huang, 913-588-4709

Study Contact, 913-945-7552

Estimated Completion Date

Saturday, November 4, 2017 #