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A151216: Lung; NSCLC; Stages IB-IIIA

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

Objective

Overview

This phase III ALCHEMIST 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.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • 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 "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 Institutional Review Board (IRB) approved
    • Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
  • For post-surgical patients

    • Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
    • Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No patients who have received neoadjuvant therapy (chemo- or radiotherapy) for this lung cancer
  • 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
  • No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4
  • No patients known to be pregnant or lactating
  • Patients who have had local genotyping are eligible, regardless of the local result
  • No patients with recurrence of lung cancer after prior resection
  • Note: Post-surgical patients should proceed to registration immediately following preregistration
  • PATIENT REGISTRATION ELIGIBILITY CRITERIA:
  • Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
  • Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
  • Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
  • 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 or radiotherapy only, register patient within 225 days following surgery
    • If adjuvant chemotherapy and radiation, register patient within 285 days following surgery

Phase: III

Learn More

ClinicalTrials.Gov

                          IRB Protocol Number
                          A151216
                          Principal Investigator(s)
                          Vikas Dembla, M.D.

                          Clinical Trial Categories

                          • Thoracic Cancer
                          • Precision Medicine- Rare Tumors
                          Sponsor(s)
                          National Cancer Institute (NCI)
                          How to Participate

                          Sue Stanley, RN

                          864-560-7252

                          sstanley@gibbscc.org

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