Randomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
Randomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery (resected). Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE:
I. To assess whether adjuvant therapy with erlotinib hydrochloride (erlotinib) will result in improved overall survival (OS) over observation for patients with completely resected stage IB (>= 4 cm)-IIIA epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) (confirmed centrally) following complete resection and standard post-operative therapy.
SECONDARY OBJECTIVES:
I. To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over observation for patients with completely resected stage IB (>= 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
II. To evaluate the safety profile of erlotinib in the adjuvant setting. III. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 and 10 years over observation for patients with completely resected stage IB (>= 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
IV. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.
V. To study detection of circulating EGFR mutations in cell-free plasma deoxyribonucleic acid (DNA) as a prognostic marker in resected early stage NSCLC.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM A (BLINDED ERLOTINIB- CLOSED 06/14/17): Blinded patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM B (PLACEBO- CLOSED 06/14/17): Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM C (UNBLINDED ERLOTINIB): Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM D (OBSERVATION): Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.
After completion of study treatment, patients are followed up every 6 months for 4 years and then yearly for 6 years.
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:
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; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results
Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
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, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration
Non-pregnant and non-lactating
No history of cornea abnormalities
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
Jonesboro, Arkansas 72401, United States
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Sacramento, California 95817, United States
West Haven, Connecticut 06516, United States
Washington D.C., District of Columbia 20002, United States
Deerfield Beach, Florida 33442, United States
Miami, Florida 33136, United States
Highland Park, Illinois 60035, United States
Louisville, Kentucky 40202, United States
Covington, Louisiana 70433, United States
Slidell, Louisiana 70458, United States
Slidell, Louisiana 70458, United States
Baltimore, Maryland 21237, United States
Brighton, Massachusetts 02135, United States
Milford, Massachusetts 01757, United States
South Weymouth, Massachusetts 02190, United States
Winchester, Massachusetts 01890, United States
Brighton, Michigan 48114, United States
Brownstown, Michigan 48183, United States
Chelsea, Michigan 48118, United States
East China Township, Michigan 48054, United States
Grand Rapids, Michigan 49503, United States
Saint Joseph, Michigan 49085, United States
Saint Joseph, Michigan 49085, United States
West Branch, Michigan 48661, United States
Ypsilanti, Michigan 48197, United States
Columbus, Mississippi 39705, United States
New Albany, Mississippi 38652, United States
North Kansas City, Missouri 64116, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89149, United States
Lebanon, New Hampshire 03756, United States
New Brunswick, New Jersey 08903, United States
Brooklyn, New York 11209, United States
Mount Kisco, New York 10549-3417, United States
New York, New York 10032, United States
Huntersville, North Carolina 28078, United States
Washington, North Carolina 27889, United States
Harrisburg, Pennsylvania 17109, United States
Johnson City, Tennessee 37604, United States
American Fork, Utah 84003, United States
Berlin Corners, Vermont 05602, United States
Silverdale, Washington 98383, United States
Spokane, Washington 99204, United States
Spokane, Washington 99218, United States
Spokane Valley, Washington 99216, United States
Yakima, Washington 98902, United States
Appleton, Wisconsin 54915, United States
Brookfield, Wisconsin 53045, United States
Franklin, Wisconsin 53132, United States
Johnson Creek, Wisconsin 53038, United States
Madison, Wisconsin 53792, United States
Mequon, Wisconsin 53097, United States
Milwaukee, Wisconsin 53210, United States
Stevens Point, Wisconsin 54482, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States
Wauwatosa, Wisconsin 53226, United States