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ALCHEMIST- Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) A screening trial for A081105, E4512 and EA5142
 
Region Sponsors
Mid-Atlantic
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
ALCHEMIST MA-18-179
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Non-Small Cell Lung Cancer (NSCLC) Patients with stage IB-IIIA that has been or will be removed by surgery
 
Purpose
The purpose of the ALCHEMIST A151216-Sequencing trial is to examine lung cancer patients’ surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.
 
Detailed Description
The investigators hypothesize that a certain genetic mutation or changes either in ALK or EGFR targeted by specific drugs would improve the cure rate of patients with early-stage NSCLC. This could then lead to the delivery of personalized genotype-directed therapies.
 
Gender Age Limit
Male & Female
 
Inclusion 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
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • 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.
  • Patients who have had local genotyping are eligible, regardless of the local result.
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • A151216
  • Oncology (Adult)
  • ALCHEMIST-Sequencing
  • Preventative Medicine
  • Lung Cancer
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)
  • Preventative Medicine


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, RN
-301-816-6768
-Leslie.K.Greenberg@kp.org
-Gaithersburg Medical Center


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