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)

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT02194738
Run by: National Cancer Institute (NCI)
People needed: 8300
Starts: 2014-09-26
Expected to finish: 2026-09-28
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:

Where it is running

AdventHealth Infusion Center Haywood — Clyde, North Carolina, United States
Durham VA Medical Center — Durham, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
CaroMont Regional Medical Center — Gastonia, North Carolina, United States
Gaston Hematology and Oncology Associates — Gastonia, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro — Goldsboro, North Carolina, United States
Wayne Memorial Hospital — Goldsboro, North Carolina, United States
Cone Health Cancer Center — Greensboro, North Carolina, United States
Cone Health Cancer Center at Drawbridge Parkway — Greensboro, North Carolina, United States
East Carolina University — Greenville, North Carolina, United States
Maria Parham Hospital — Henderson, North Carolina, United States
Margaret R Pardee Memorial Hospital — Hendersonville, North Carolina, United States
AdventHealth Hendersonville — Hendersonville, North Carolina, United States
Hayworth Cancer Center — High Point, North Carolina, United States
Novant Health Cancer Institute - Huntersville — Huntersville, North Carolina, United States
Southern Oncology Specialists-Huntersville — Huntersville, North Carolina, United States
Onslow Memorial Hospital — Jacksonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville — Jacksonville, North Carolina, United States
ECU Health Oncology Kenansville — Kenansville, North Carolina, United States
ECU Health Oncology Kinston — Kinston, North Carolina, United States
Scotland Memorial Hospital-Laurinburg Cancer Center — Laurinburg, North Carolina, United States
Southeastern Regional Medical Center — Lumberton, North Carolina, United States
Matthews Radiation Oncology Center — Matthews, North Carolina, United States
Novant Health Cancer Institute - Matthews — Matthews, North Carolina, United States
Southeastern Medical Oncology Center-Clinton — Clinton, North Carolina, United States

Full record on ClinicalTrials.gov

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