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 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
Inclusion Criterea
- 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
Participating Clinics
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Las Vegas Cancer Center-Medical Center
Comprehensive Cancer Centers of Nevada - Central Valley
Cancer Therapy and Integrative Medicine
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
OptumCare Cancer Care at Fort Apache
Cancer and Blood Specialists-Shadow
Comprehensive Cancer Centers of Nevada - Town Center
Summerlin Hospital Medical Center
Cancer and Blood Specialists-Tenaya
Radiation Oncology Associates
Sunrise Hospital and Medical Center
Las Vegas Cancer Center-Henderson
Renown Regional Medical Center
Hope Cancer Care of Nevada-Pahrump
OptumCare Cancer Care at Seven Hills
Radiation Oncology Centers of Nevada Central
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Kingman Regional Medical Center
Comprehensive Cancer Centers of Nevada - Northwest
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
GenesisCare USA - Fort Apache
OptumCare Cancer Care at MountainView
OptumCare Cancer Care at Charleston
GenesisCare USA - Vegas Tenaya
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Lake Huron Medical Center
GenesisCare USA - Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Comprehensive Cancer Centers of Nevada-Summerlin
GenesisCare USA - Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Comprehensive Cancer Centers of Nevada
Carson Tahoe Regional Medical Center
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Saint Mary's Regional Medical Center
Radiation Oncology Centers of Nevada Southeast
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Hope Cancer Care of Nevada
University Medical Center of Southern Nevada
Cancer and Blood Specialists-Henderson
Urology Specialists of Nevada - Green Valley
Urology Specialists of Nevada - Southwest
Las Vegas Prostate Cancer Center
Las Vegas Urology - Pebble
Las Vegas Urology - Cathedral Rock
Las Vegas Urology - Sunset
Las Vegas Urology - Pecos
Urology Specialists of Nevada - Central
Las Vegas Urology - Green Valley
Urology Specialists of Nevada - Northwest