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Clinical Trials in Norway / NCT02193282
Active, not recruiting Phase 3

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)

NCT02193282 · tracked via the Priya Life Science Norway tracker
Phase
Phase 3
Started
2015-02-11
Last updated
2026-07-02

Condition(s) studied

Lung Non-Squamous Non-Small Cell CarcinomaStage IB Lung Non-Small Cell Carcinoma AJCC v7Stage II Lung Non-Small Cell Cancer AJCC v7Stage IIA Lung Non-Small Cell Carcinoma AJCC v7Stage IIB Lung Non-Small Cell Carcinoma AJCC v7Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Investigational drug(s) / intervention(s)

Clinical ObservationErlotinib Hydrochloride →Laboratory Biomarker AnalysisPlacebo Administration

Clinical Observation: Undergo observation

Erlotinib Hydrochloride: Given PO

Laboratory Biomarker Analysis: Correlative studies

Placebo Administration: Given PO

Study summary

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)

Trial sites (1407)

FacilityCityRegionStatus
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 Norway

Other trials for the same condition

Official registry record

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.

View NCT02193282 on ClinicalTrials.gov ↗ ← All trials in Norway