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Genetic Testing in Screening Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

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

  • Clinical Trial Information

    Trial Contact: Deronvil, France; De Leon, Ma Theresa

    Trial Phone: 321.841.3498 ; 321.841.8284

  • IRB No: C21.023.02

    Protocol Abbrev: Alchemist A151216

    Principal Investigator: Jennifer E. Tseng, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: A151216

    Treatment: Screening: clinical genotyping for adjuvant targeted therapies

    Therapies Involved: Oncology: Adjuvant

    ClinicalTrials.gov ID: NCT02194738

  • Objective

    To centrally test resected NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies.

  • Key Eligibility

    •  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 "nonsquamous" histology; patients with squamous cell carcinoma are eligible

    Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized


    •  For post-surgical patients
    Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy
    ◦Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized