Trial Search Results

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)

This 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Intervention(s):

  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis

Eligibility


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 >=
      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 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 >= 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Martina Steffen
650-721-4077
Recruiting