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

ENROLLING
Protocol # :
15-700
Conditions
Stage IIA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Phase
III
Disease Sites
Lung
Principal Investigator
Shemmeri, Ealaf
Site Investigator
Briccetti, Frederick
Constantine, Michael
Costa, Daniel
Dagogo-Jack, Ibiayi
Faggen, Meredith, G.
Gainor, Justin
Lathan, Christopher, S.
Manera, Lisa, Marie
Oxnard, Geoffrey, R.
Rao, Revati
Site Research Nurses
Andan, Christine
Becker, Simone
Brule, Maurice, N.
Burke, Millicent
Caradonna, Lisa
Cronis, Charles, Lewis
Doyle, Diane, P.
Drevers, Dawn
Farquhar, Mary
Finn, Kristen
Fleming, Norah, Michelle
Freeman, Stefani, Danielle
Fuller, Frances
Gentile, Alissa
Ginter, Lindsey
Hennessy, Kerry
Hixon, Nicole, R.
Houghton, Nicole
Hurley, Meaghan
Janell, Samantha
Kelley, Elaine
Kosinski, Michelle
Kuberski, Heather, D.
Lucca, Joan
Lyons, Hannah, Felton
Maloof, Damiana, M.
McGovern, Lauren
Mcnally, Megan
Milton, Gillian, C.
Morse, Linda, K.
O'Neil, Kelly
Piper, Audrey, L.

Trial Description

This 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.

Eligibility Requirements

Inclusion Criteria:

- PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:

- 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 IIIA, II (IIA or IIB) or large IB (defined as size >=
4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural
invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of
American Joint Committee on Cancer (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 IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm);
Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural
invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of
AJCC staging will be utilized

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Age ≥ 18 years

- 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

- PATIENT REGISTRATION ELIGIBILITY CRITERIA:

- Tissue available for the required analyses (either clinical tissue block or slides and
scrolls)

- 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 IIIA, IIA or IIB, or large IB (defined as size >= 4 cm); Note: IB
tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not
eligible unless the tumor size is >= 4 cm; the 7th 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:

- If no adjuvant therapy, register patient within 75 days following surgery

- If adjuvant chemotherapy or radiotherapy only, register patient within 225
days following surgery

- If adjuvant chemotherapy and radiation, register patient within 285 days
following surgery

15-700