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)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lung Non-Squamous Non-Small Cell Carcinoma, Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Non-Small Cell Carcinoma AJCC v7, Stage IIB Lung Non-Small Cell Carcinoma AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7

In brief

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.

Key facts

Study ID: NCT02193282
Run by: National Cancer Institute (NCI)
People needed: 390
Starts: 2015-02-11
Expected to finish: 2027-02-03
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

Where it is running

Southern Cancer Center PC-Daphne — Daphne, Alabama, United States
Southern Cancer Center PC-Mobile — Mobile, Alabama, United States
Southern Cancer Center PC-Providence — Mobile, Alabama, United States
Southern Cancer Center PC-Springhill — Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States
Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
Alaska Regional Hospital — Anchorage, Alaska, United States
Alaska Women's Cancer Care — Anchorage, Alaska, United States
Anchorage Oncology Centre — Anchorage, Alaska, United States
Katmai Oncology Group — Anchorage, Alaska, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States
Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
John L McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim — Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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