Details
Title Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
IRB A151216
CC 14-1419
Hospital Akron, Fairview, Florida Weston, Hillcrest, Independence, Main Campus, Mansfield, North Coast Cancer, South Pointe, Strongsville, Wooster
Stage Stage 2, Stage 3
Disease Lung
Description
Primary Objectives- To centrally test resected NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies.
- 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).
- 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.
- To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.
- To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
- To understand reasons behind lack of enrollment to adjuvant targeted therapy studies for potentially eligible patients.
- To study the clinical significance of circulating tumor DNA within the plasma cell-free DNA (cfDNA) from early stage lung cancer patients.
Inclusion Criteria
3.1 Patient Pre-registration Eligibility Criteria
Sites should enroll patients on A151216 only if the patient is planning to register to one of the ALCHEMIST treatment trials (A081801 and E4512).
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.
• Suspected clinical stage of IIA, IIB, IIIA or IIIB (T3-4N2). The 8th edition of 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 they have not received adjuvant therapy.
• Pathologic stage IIA, IIB, IIIA or IIIB (T3-4N2). The 8th edition of AJCC staging will be utilized.
For all patients
• ECOG Performance Status 0-1
• Age ≥ 18 years
• No patients who have received neoadjuvant therapy (chemotherapy, targeted therapy or radiotherapy) 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 pre-registration.
3.2 Patient Registration Eligibility Criteria
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls, see Section 5.1)
• Completely resected NSCLC with negative margins (R0). Cancers with a histology of “adenosquamous” are considered a type of adenocarcinoma and thus a “nonsquamous” histology.
• Pathologic stage IIA, IIB, IIIA or IIIB (T3-4N2). The 8th edition of AJCC staging will be utilized.
• Patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy.
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows:
Squamous patients:
• No adjuvant therapy permitted, register patient within 77 days following surgery
Non-squamous patients:
1. If no adjuvant therapy, register patient within 77 days following surgery.
2. If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery.
3. If adjuvant chemotherapy and radiation, register patient within 285 days following surgery.
