Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lung Non-Squamous Non-Small Cell Carcinoma
Stage IB Lung Non-Small Cell Carcinoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 remove...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
February 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT02193282
Start Date
February 11 2015
End Date
October 10 2026
Last Update
January 9 2026
Active Locations (1409)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Southern Cancer Center PC-Daphne
Daphne, Alabama, United States, 36526
3
Southern Cancer Center PC-Mobile
Mobile, Alabama, United States, 36607
4
Southern Cancer Center PC-Providence
Mobile, Alabama, United States, 36608