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Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Description

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. Objective: The primary objectives are to centrally genotype resected lung adenocarcinomas for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangements to facilitate accrual to randomized adjuvant studies, and 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). Intervention: Cytology specimen collection procedure; correlative studies; cytologic sampling; and laboratory biomarker analysis. Study Population: Participants 18 years or older with stage IB-IIIA non-small cell lung cancer. Study Methodology: Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing. Follow up: After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years. Primary Endpoint: 1. Central clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105, as measured by rate of accrual [ Time Frame: Up to 4 years ] 2. Feasibility of research grade FFPE tissue collection for CCG analysis, as measured by adequate specimens collected per month [ Time Frame: Up to 4 years ] Statistics: It is estimated that up to 8000 patients may need to be genotyped in order to fully accrue to the EGFR (estimated prevalence 15%) and ALK (estimated prevalence 5%) studies. Analysis: Accrual rate to the adjuvant erlotinib and crizotinib studies will be monitored every 3 months, and discussed between the study teams coordinating the ALCHEMIST study and the adjuvant studies. If accrual is inadequate, then the ALCHEMIST study will initiate strategies to improve accrual, including opening the screening study at new centers and developing strategies for genotyping at participating centers to improve catchment.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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

Sites

Please contact Carryl Du Bois to learn more about where you can participate in this trial. Please use the contact form on the right side.

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