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  • Cancer Type: Thoracic
  • Study Type: Diagnostic
  • NCT#: NCT02194738
  • Phase: Phase III
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  • Overview

    Study Title:

    Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Summary:

    The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

    Objective:

    Screening Component: 1 Primary Objectives: 1.1 To centrally genotype resected lung adenocarcinomas for EGFR mutations and ALK rearrangements to facilitate accrual to randomized adjuvant studies. 1.2 To obtain clinically annotated tumor tissue and patient-matched non-malignant DNA from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the NCI Center for Cancer Genomics (CCG). 2 Secondary Objectives: 2.1 To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined subpopulations in the adjuvant and recurrent settings. 2.2 To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.

  • Treatments

    Medications:

    Not Applicable ()

  • Inclusion Criteria

      PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
    • For pre-surgical patients: Suspected diagnosis of resectable non-small cell lung cancer; Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsequamous" histology. Patients with squamous cell carcinoma are eligible.
    • Suspected clinical stage of IIA, IIB, IIIA or IIIB (T304N2)
    • For post-surgical patients: Completely resected non-small cell lung cancer; Pathologic stage IIIA, IIB, IIIA or IIIB (T3-4N2)
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    • No patients who have received neoadjuvant therapy (chemotherapy, targeted therapy or radiotherapy) for this lung cancer.
    • No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas; a secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216.
    • No prior treatment with agents targeting Epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement.
    • Non-lactating and no patients known to be pregnant.
    • Patients who have had local genotyping are eligible, regardless of the local result.
    • Note: Post-surgical patients should proceed to registration immediately following preregistration. PATIENT REGISTRATION ELIGIBILITY CRITERIA:
    • Completely resected non-squamous NSCLC; eligible histologic subtypes include adenocarcinoma, adenosquamous carcinoma, or large cell/poorly differentiated non-small cell lung cancer (NSCLC) as long as squamous carcinoma is not favored; patients with pure squamous carcinoma are not eligible.
    • Pathologic stage IIA, IIB, IIIA or IIIB (T3-4N2).
    • Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already locally tested for EGFR and ALK.
    • In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach: If no adjuvant therapy, register patient within 75 days following surgery; If adjuvant chemotherapy only, register patient within 165 days following surgery; If adjuvant chemotherapy and radiation, register patient within 225 days following surgery.
  • Exclusion Criteria

    • Does not meet Inclusion Criteria

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