Last updated on November 2019

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)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Non-Small Cell Lung Cancer AJCC v7 | Stage IB Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIA Squamous Cell Lung Carcinoma AJCC v7 | Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIB Squamous Cell Lung Carcinoma AJCC v7 | Lung Large Cell Carcinoma | Stage IIB Lung Squamous Cell Carcinoma AJCC v7 | Stage IB Squamous Cell Lung Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Large Cell Lung Carcinoma | Stage II Squamous Cell Lung Carcinoma AJCC v7 | Lung Adenocarcinoma | Stage IB Lung Squamous Cell Carcinoma AJCC v7 | Stage IIIA Lung Squamous Cell Carcinoma AJCC v7 | Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIA Lung Squamous Cell Carcinoma AJCC v7 | Stage II Lung Squamous Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Squamous Cell Lung Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 "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 >= 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 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 < 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
  • 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 locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year 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 >= 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
  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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