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 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Intervention(s):

  • Other: Clinical Observation
  • Drug: Crizotinib
  • Other: Cytology Specimen Collection Procedure
  • Drug: Erlotinib Hydrochloride
  • Biological: Nivolumab
  • Other: Placebo

Phase:

Phase 3

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 >=
      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

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
Lisa Zhou
650-736-4112
Recruiting