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Alliance A151216: ALCHEMIST - Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial
Description
This phase III ALCHEMIST 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.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
- 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 only if the registering site has EA5142 Institutional Review Board (IRB) approved
- Suspected clinical stage of IIIA, II (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
- For post-surgical patients
- Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
- Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
- 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 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 preregistration