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)

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.

Eligibility Criteria

Inclusion Criteria:

- PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:

- For pre-surgical patients

- Suspected diagnosis of resectable non-small cell lung cancer

- Suspected clinical stage of IIIA, II or large IB (defined as size >= 4cm)

- For post-surgical patients

- Completely resected non-small cell lung cancer

- 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 or 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 IIIA, II, or large IB (defined as size >= 4 cm)

- 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

Principal Investigator

Chao H. Huang, 913-588-4709

Study Contact

ctnursenav@kumc.edu, 913-945-7552

ClinicalTrials.gov #

NCT02194738
06/02/2015