Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
The purpose of this research study 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.
1 Primary Objectives:
1.1 To centrally genotype resected lung adenocarcinomas for EGFR mutations and ALK rearrangements to facilitate accrual to randomized adjuvant studies.
1.2 To obtain clinically annotated tumor tissue and patient-matched non-malignant 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 NCI Center for Cancer Genomics (CCG).
2 Secondary Objectives:
2.1 To characterize the natural history of EGFR and ALK wild-type lung cancers to allow subsequent development of targeted therapies against genotype-defined subpopulations in the adjuvant and recurrent settings.
2.2 To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
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 "nonsequamous" histology. Patients with squamous cell carcinoma are eligible.
Suspected clinical stage of IIA, IIB, IIIA or IIIB (T304N2)
For post-surgical patients: Completely resected non-small cell lung cancer; Pathologic stage IIIA, IIB, IIIA or IIIB (T3-4N2)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
No patients who have received neoadjuvant therapy (chemotherapy, targeted therapy or radiotherapy) 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 Epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement.
Non-lactating and no patients known to be pregnant.
Patients who have had local genotyping are eligible, regardless of the local result.
Note: Post-surgical patients should proceed to registration immediately following preregistration.
PATIENT REGISTRATION ELIGIBILITY CRITERIA:
Completely resected non-squamous NSCLC; eligible histologic subtypes include adenocarcinoma, adenosquamous carcinoma, or large cell/poorly differentiated non-small cell lung cancer (NSCLC) as long as squamous carcinoma is not favored; patients with pure squamous carcinoma are not eligible.
Pathologic stage IIA, IIB, IIIA or IIIB (T3-4N2).
Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already locally tested for EGFR and ALK.
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 165 days following surgery; If adjuvant chemotherapy and radiation, register patient within 225 days following surgery.
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