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)

Not Recruiting

Trial ID: NCT02193282


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.

Official Title

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology


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

   - 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


drug: Erlotinib Hydrochloride

other: Laboratory Biomarker Analysis

other: Clinical Observation

other: Placebo Administration

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Julie Thu Mai Nguyen

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