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A081105: Lung; NSCLC; Stages IB-IIIA

Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Objective

Overview

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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • 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 radiotherapy) for this lung cancer
  • Complete recovery from surgery and standard postoperative 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
  • 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

Phase: III

Learn More

ClinicalTrials.Gov

IRB Protocol Number
A081105
Principal Investigator(s)
Vikas Dembla, M.D.

Clinical Trial Categories

  • Thoracic Cancer
Sponsor(s)
National Cancer Institute (NCI)
How to Participate

Sue Stanley, RN
864-560-7252
sstanley@gibbscc.org

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