Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: 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)

Summary: This research 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.

Detailed description: PRIMARY OBJECTIVES:
  I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to facilitate accrual to randomized adjuvant studies.
  II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
  SECONDARY OBJECTIVES:
  I. To characterize the natural history of molecularly characterized NSCLC to allow subsequent development of targeted therapies against genotype-defined subpopulations in the adjuvant and recurrent settings.
  II. To cross-validate local genotyping assays for epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) with a central reference standard.
  TERTIARY OBJECTIVES:
  I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
  II. To understand reasons behind lack of enrollment to adjuvant targeted therapy studies for potentially eligible patients.
  OUTLINE:
  Patients undergo collection of blood and tissue samples for EGFR, ALK, and programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1)/cytotoxic t-lymphocyte-associated protein 4 (CTLA-4) testing via direct sequencing, fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
  After completion of study, patients that are not enrolled on either A081105, E4512, or EA5142 are followed up every 6 months for 5 years.

Eligibility: Inclusion Criteria:
  -  PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
  -  For pre-surgical patients
  -  Suspected diagnosis of resectable non-small cell lung cancer; 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 or large IB (defined as size >= 4cm)
  -  For post-surgical patients
  -  Completely resected non-small cell lung cancer; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
  -  Pathologic stage IIIA, II or IB (defined as size >= 4 cm)
  -  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 prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas; a secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216
  -  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; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
  -  Pathologic stage IIIA, II, or large IB (defined as size >= 4 cm)
  -  Tissue available for the required analyses
  -  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 only, register patient within 225 days following surgery
  -  If adjuvant chemotherapy and radiation, register patient within 285 days following surgery

Relevance to patient case: not relevant