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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Overall survival (OS) — The time from randomization until death, assessed up to 10 years Estimated using the method of Kaplan-Meier survival curves and a 1-sided stratified log rank test (accounting for all the stratification factors) will be used to compare OS between the two arms. Cox proportional hazards model (including time varying coefficients as necessary) will be used to assess whether the distribution of OS times differ with respect to treatment regimen after having adjusted for the stratification factors as well as other potential prognostic and treatment covariates.
Trial sites (1407)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Southern Cancer Center PC-Daphne
Daphne
Alabama
Southern Cancer Center PC-Mobile
Mobile
Alabama
Southern Cancer Center PC-Providence
Mobile
Alabama
Southern Cancer Center PC-Springhill
Mobile
Alabama
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
Fairbanks Memorial Hospital
Fairbanks
Alaska
Mayo Clinic Hospital in Arizona
Phoenix
Arizona
Mayo Clinic in Arizona
Scottsdale
Arizona
Banner University Medical Center - Tucson
Tucson
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
John L McClellan Memorial Veterans Hospital
Little Rock
Arkansas
Kaiser Permanente-Anaheim
Anaheim
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
PCR Oncology
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
California
Kaiser Permanente-Baldwin Park
Baldwin Park
California
Kaiser Permanente-Bellflower
Bellflower
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
California
Mills-Peninsula Medical Center
Burlingame
California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
California
Mercy San Juan Medical Center
Carmichael
California
Eden Hospital Medical Center
Castro Valley
California
Community Cancer Institute
Clovis
California
University Oncology Associates
Clovis
California
John Muir Medical Center-Concord
Concord
California
+ 1367 more sites — see the full list on the official registry below.
More National Cancer Institute (NCI) trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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