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