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 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.
Description
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.
Who can participate
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 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
Interventions
Clinical Observation
OTHER
Erlotinib Hydrochloride
DRUG
Laboratory Biomarker Analysis
OTHER
Placebo Administration
OTHER
Locations
1409
Puerto Rico (4)
Cancer Center-Metro Medical Center Bayamon
Bayamón
Doctors Cancer Center
Manati
San Juan Community Oncology Group
San Juan
San Juan City Hospital
San Juan
United States (1405)
Hawaii Cancer Care - Westridge
‘Aiea , Hawaii
Pali Momi Medical Center
‘Aiea , Hawaii
Queen's Cancer Center - Pearlridge
‘Aiea , Hawaii
The Cancer Center of Hawaii-Pali Momi
‘Aiea , Hawaii
Providence Regional Cancer System-Aberdeen
Aberdeen , Washington
Hendrick Medical Center
Abilene , Texas
Hickman Cancer Center
Adrian , Michigan
Cleveland Clinic Akron General
Akron , Ohio
Phoebe Putney Memorial Hospital
Albany , Georgia
Lovelace Medical Center-Downtown
Albuquerque , New Mexico
Lovelace Medical Center-Saint Joseph Square
Albuquerque , New Mexico
Hematology Oncology Associates
Albuquerque , New Mexico
University of New Mexico Cancer Center
Albuquerque , New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque , New Mexico
Presbyterian Kaseman Hospital
Albuquerque , New Mexico
Christus Saint Frances Cabrini Hospital
Alexandria , Louisiana
Lehigh Valley Hospital-Cedar Crest
Allentown , Pennsylvania
MyMichigan Medical Center Gratiot
Alma , Michigan
MyMichigan Medical Center Alpena
Alpena , Michigan
AdventHealth Altamonte
Altamonte Springs , Florida
The Don and Sybil Harrington Cancer Center
Amarillo , Texas
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork , Utah
Mary Greeley Medical Center
Ames , Iowa
McFarland Clinic - Ames
Ames , Iowa
Community Hospital of Anaconda
Anaconda , Montana
Cancer Care Center at Island Hospital
Anacortes , Washington
Kaiser Permanente-Anaheim
Anaheim , California
Anchorage Associates in Radiation Medicine
Anchorage , Alaska
Anchorage Radiation Therapy Center
Anchorage , Alaska
Alaska Breast Care and Surgery LLC
Anchorage , Alaska
Alaska Oncology and Hematology LLC
Anchorage , Alaska
Alaska Regional Hospital
Anchorage , Alaska
Alaska Women's Cancer Care
Anchorage , Alaska
Anchorage Oncology Centre
Anchorage , Alaska
Katmai Oncology Group
Anchorage , Alaska
Providence Alaska Medical Center
Anchorage , Alaska
AnMed Health Cancer Center
Anderson , South Carolina
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor , Michigan
University of Michigan Rogel Cancer Center
Ann Arbor , Michigan
Luminis Health Anne Arundel Medical Center
Annapolis , Maryland
Langlade Hospital and Cancer Center
Antigo , Wisconsin
Kaiser Permanente-Deer Valley Medical Center
Antioch , California
Fox Valley Surgical Associates Limited
Appleton , Wisconsin
ThedaCare Regional Cancer Center
Appleton , Wisconsin
ThedaCare Regional Medical Center - Appleton
Appleton , Wisconsin
Ascension Saint Elizabeth Hospital
Appleton , Wisconsin
PCR Oncology
Arroyo Grande , California
Randolph Hospital
Asheboro , North Carolina
Mission Hospital
Asheville , North Carolina
AdventHealth Infusion Center Asheville
Asheville , North Carolina
Messino Cancer Centers
Asheville , North Carolina
King's Daughter's Medical Center
Ashland , Kentucky
Duluth Clinic Ashland
Ashland , Wisconsin
University Cancer and Blood Center LLC
Athens , Georgia
Emory University Hospital Midtown
Atlanta , Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta , Georgia
Emory Saint Joseph's Hospital
Atlanta , Georgia
Northside Hospital
Atlanta , Georgia
MultiCare Auburn Medical Center
Auburn , Washington
Sutter Auburn Faith Hospital
Auburn , California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn , California
Augusta University Medical Center
Augusta , Georgia
Harold Alfond Center for Cancer Care
Augusta , Maine
Rush-Copley Medical Center
Aurora , Illinois
Rocky Mountain Cancer Centers-Aurora
Aurora , Colorado
The Medical Center of Aurora
Aurora , Colorado
Rocky Mountain Regional VA Medical Center
Aurora , Colorado
UCHealth University of Colorado Hospital
Aurora , Colorado
Dell Seton Medical Center at The University of Texas
Austin , Texas
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura , Florida
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island , Washington
Saint Alphonsus Cancer Care Center-Baker City
Baker City , Oregon
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield , California
Kaiser Permanente-Baldwin Park
Baldwin Park , California
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin , Missouri
University of Maryland/Greenebaum Cancer Center
Baltimore , Maryland
Greater Baltimore Medical Center
Baltimore , Maryland
Sinai Hospital of Baltimore
Baltimore , Maryland
MedStar Union Memorial Hospital
Baltimore , Maryland
MedStar Harbor Hospital
Baltimore , Maryland
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore , Maryland
Kaiser Permanente-Woodlawn Medical Center
Baltimore , Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore , Maryland
Eastern Maine Medical Center
Bangor , Maine
Flaget Memorial Hospital
Bardstown , Kentucky
Memorial Sloan Kettering Basking Ridge
Basking Ridge , New Jersey
LSU Health Baton Rouge-North Clinic
Baton Rouge , Louisiana
Our Lady of the Lake Physician Group
Baton Rouge , Louisiana
Louisiana Hematology Oncology Associates LLC
Baton Rouge , Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge , Louisiana
Ochsner Health Center-Summa
Baton Rouge , Louisiana
Medical Center of Baton Rouge
Baton Rouge , Louisiana
Ochsner High Grove
Baton Rouge , Louisiana
Bronson Battle Creek
Battle Creek , Michigan
Northwell Health Imbert Cancer Center
Bay Shore , New York
UHHS-Chagrin Highlands Medical Center
Beachwood , Ohio
UPMC-Heritage Valley Health System Beaver
Beaver , Pennsylvania
Indu and Raj Soin Medical Center
Beavercreek , Ohio
UM Upper Chesapeake Medical Center
Bel Air , Maryland
MaineHealth Waldo Hospital
Belfast , Maine
Overlake Medical Center
Bellevue , Washington
Kaiser Permanente-Bellflower
Bellflower , California
PeaceHealth Saint Joseph Medical Center
Bellingham , Washington
Gaston Hematology and Oncology Associates-Belmont
Belmont , North Carolina
Strecker Cancer Center-Belpre
Belpre , Ohio
Sanford Joe Lueken Cancer Center
Bemidji , Minnesota
Saint Charles Health System
Bend , Oregon
Southwestern Vermont Medical Center
Bennington , Vermont
Alta Bates Summit Medical Center-Herrick Campus
Berkeley , California
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners , Vermont
Walter Reed National Military Medical Center
Bethesda , Maryland
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem , Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem , Pennsylvania
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf , Iowa
Beverly Hospital
Beverly , Massachusetts
MaineHealth Maine Medical Center - Biddeford
Biddeford , Maine
Billings Clinic Cancer Center
Billings , Montana
Saint Vincent Healthcare
Billings , Montana
Saint Vincent Frontier Cancer Center
Billings , Montana
University of Alabama at Birmingham Cancer Center
Birmingham , Alabama
Sanford Bismarck Medical Center
Bismarck , North Dakota
OSF Saint Joseph Medical Center
Bloomington , Illinois
Illinois CancerCare-Bloomington
Bloomington , Illinois
Boca Raton Regional Hospital
Boca Raton , Florida
Prisma Health Cancer Institute - Spartanburg
Boiling Springs , South Carolina
Saint Alphonsus Cancer Care Center-Boise
Boise , Idaho
Saint Luke's Cancer Institute - Boise
Boise , Idaho
Central Care Cancer Center - Bolivar
Bolivar , Missouri
Parkland Health Center-Bonne Terre
Bonne Terre , Missouri
McFarland Clinic - Boone
Boone , Iowa
Massachusetts General Hospital Cancer Center
Boston , Massachusetts
Brigham and Women's Hospital
Boston , Massachusetts
Boston Medical Center
Boston , Massachusetts
Beth Israel Deaconess Medical Center
Boston , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
Rocky Mountain Cancer Centers-Boulder
Boulder , Colorado
Bozeman Health Deaconess Hospital
Bozeman , Montana
Essentia Health Saint Joseph's Medical Center
Brainerd , Minnesota
Cox Cancer Center Branson
Branson , Missouri
Lafayette Family Cancer Center-EMMC
Brewer , Maine
Ocean University Medical Center
Brick , New Jersey
United Hospital Center
Bridgeport , West Virginia
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton , Massachusetts
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton , Michigan
Trinity Health Medical Center - Brighton
Brighton , Michigan
Ballad Health Cancer Care - Bristol
Bristol , Virginia
Bristol Regional Medical Center
Bristol , Tennessee
Wellmont Medical Associates Oncology and Hematology-Bristol
БГ