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)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 14-006631
    • Rochester, Minnesota: 14-006631
    NCT ID: NCT02194738
    Sponsor Protocol Number: A151216

About this study

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
  • For pre-surgical patients

    • Suspected diagnosis of resectable non-small cell lung cancer
    • Suspected clinical stage of IIIA, II or large IB (defined as size ≥ 4cm)
  • For post-surgical patients

    • Completely resected non-small cell lung cancer
    • Pathologic stage IIIA, II or IB (defined as size ≥ 4 cm)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No patients who have received neoadjuvant therapy (chemo- or radio-therapy) 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 EGFR mutation or 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 IIIA, II, or large IB (defined as size ≥ 4 cm)
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20144048

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