Active (not recruiting)
Not applicable
NCT02194738
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)
No applicable phase (e.g. observational)
Conditions:
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
Sponsor: National Cancer Institute (NCI)
trial.available_in:
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Overview
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.
Description
PRIMARY OBJECTIVES:
I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to facilitate accrual to randomized adjuvant studies.
II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).
SECONDARY OBJECTIVES:
I. To characterize the natural history of molecularly characterized NSCLC to allow subsequent development of targeted therapies against genotype-defined subpopulations in the adjuvant and recurrent settings.
II. To cross-validate local genotyping assays for EGFR and ALK and PD-L1 immunohistochemistry (IHC) with a central reference standard, when available.
EXPLORATORY/OTHER OBJECTIVES:
I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.
II. To understand reasons behind lack of enrollment to adjuvant targeted therapy studies for potentially eligible patients.
III. To study the clinical significance of circulating tumor DNA within the plasma cell-free DNA (cfDNA) from early stage lung cancer patients.
IV. To perform proteomic analyses on lung cancer specimens obtained at the time of resection (to identify prognostic biomarkers).
OUTLINE:
STEP 1 (SCREENING): Patients undergo collection of blood and tissue samples for EGFR, ALK, and programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1)/cytotoxic t-lymphocyte-associated protein 4 (CTLA-4) testing via direct sequencing, fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.
STEP 2 (TREATMENT): Patients with a mutation targeted by one or more of the investigational drugs used in this study or those without mutations are assigned to 1 of 4 treatment subprotocols.
A081105: Patients are randomized to 1 of 4 treatment arms.
ARM A (BLINDED ERLOTINIB- CLOSED 06/14/17): Blinded patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM B (PLACEBO- CLOSED 06/14/17): Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM C (UNBLINDED ERLOTINIB): Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM D (OBSERVATION): Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.
E4512: Patients are randomized to 1 of 2 treatment
Who can participate
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
Interventions
Biospecimen Collection
PROCEDURE
Carboplatin
DRUG
Cisplatin
DRUG
Clinical Observation
OTHER
Computed Tomography
PROCEDURE
Crizotinib
DRUG
Cytology Specimen Collection Procedure
OTHER
Echocardiography Test
PROCEDURE
Erlotinib
DRUG
Gemcitabine Hydrochloride
DRUG
Nivolumab
BIOLOGICAL
Paclitaxel
DRUG
Pembrolizumab
BIOLOGICAL
Pemetrexed
DRUG
Pemetrexed Disodium
DRUG
Placebo Administration
OTHER
Positron Emission Tomography
PROCEDURE
Locations
1663
Guam (1)
FHP Health Center-Guam
Tamuning
Puerto Rico (4)
Cancer Center-Metro Medical Center Bayamon
Bayamón
Doctors Cancer Center
Manati
San Juan Community Oncology Group
San Juan
San Juan City Hospital
San Juan
United States (1658)
Hawaii Cancer Care - Westridge
‘Aiea , Hawaii
Pali Momi Medical Center
‘Aiea , Hawaii
Queen's Cancer Center - Pearlridge
‘Aiea , Hawaii
Straub Pearlridge Clinic
‘Aiea , Hawaii
The Cancer Center of Hawaii-Pali Momi
‘Aiea , Hawaii
The Queen's Medical Center - West Oahu
‘Ewa Beach , Hawaii
UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen , Maryland
Providence Regional Cancer System-Aberdeen
Aberdeen , Washington
Hendrick Medical Center
Abilene , Texas
Hickman Cancer Center
Adrian , Michigan
Riverwood Healthcare Center
Aitkin , Minnesota
Cleveland Clinic Akron General
Akron , Ohio
Phoebe Putney Memorial Hospital
Albany , Georgia
Lovelace Medical Center-Downtown
Albuquerque , New Mexico
Lovelace Medical Center-Saint Joseph Square
Albuquerque , New Mexico
Hematology Oncology Associates
Albuquerque , New Mexico
University of New Mexico Cancer Center
Albuquerque , New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque , New Mexico
Presbyterian Kaseman Hospital
Albuquerque , New Mexico
University Cancer Specialists - Alcoa
Alcoa , Tennessee
Christus Saint Frances Cabrini Hospital
Alexandria , Louisiana
Lehigh Valley Hospital-Cedar Crest
Allentown , Pennsylvania
Saint Luke's Cancer Center - Allentown
Allentown , Pennsylvania
Aultman Alliance Community Hospital
Alliance , Ohio
MyMichigan Medical Center Gratiot
Alma , Michigan
MyMichigan Medical Center Alpena
Alpena , Michigan
AdventHealth Altamonte
Altamonte Springs , Florida
OSF Saint Anthony's Health Center
Alton , Illinois
UPMC Altoona
Altoona , Pennsylvania
The Don and Sybil Harrington Cancer Center
Amarillo , Texas
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork , Utah
Mary Greeley Medical Center
Ames , Iowa
McFarland Clinic - Ames
Ames , Iowa
Community Hospital of Anaconda
Anaconda , Montana
Cancer Care Center at Island Hospital
Anacortes , Washington
Kaiser Permanente-Anaheim
Anaheim , California
Anchorage Associates in Radiation Medicine
Anchorage , Alaska
Anchorage Radiation Therapy Center
Anchorage , Alaska
Alaska Breast Care and Surgery LLC
Anchorage , Alaska
Alaska Oncology and Hematology LLC
Anchorage , Alaska
Alaska Regional Hospital
Anchorage , Alaska
Alaska Women's Cancer Care
Anchorage , Alaska
Anchorage Oncology Centre
Anchorage , Alaska
Katmai Oncology Group
Anchorage , Alaska
Providence Alaska Medical Center
Anchorage , Alaska
AnMed Health Cancer Center
Anderson , South Carolina
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny , Iowa
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor , Michigan
University of Michigan Rogel Cancer Center
Ann Arbor , Michigan
Luminis Health Anne Arundel Medical Center
Annapolis , Maryland
Langlade Hospital and Cancer Center
Antigo , Wisconsin
Kaiser Permanente-Deer Valley Medical Center
Antioch , California
Fox Valley Surgical Associates Limited
Appleton , Wisconsin
ThedaCare Regional Cancer Center
Appleton , Wisconsin
ThedaCare Regional Medical Center - Appleton
Appleton , Wisconsin
Ascension Saint Elizabeth Hospital
Appleton , Wisconsin
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande , California
PCR Oncology
Arroyo Grande , California
Cone Health Cancer Center at Asheboro
Asheboro , North Carolina
Randolph Hospital
Asheboro , North Carolina
Cone Health MedCenter Asheboro
Asheboro , North Carolina
Mission Hospital
Asheville , North Carolina
AdventHealth Infusion Center Asheville
Asheville , North Carolina
Messino Cancer Centers
Asheville , North Carolina
Duluth Clinic Ashland
Ashland , Wisconsin
Northwest Wisconsin Cancer Center
Ashland , Wisconsin
King's Daughter's Medical Center
Ashland , Kentucky
OhioHealth O'Bleness Hospital
Athens , Ohio
University Cancer and Blood Center LLC
Athens , Georgia
Emory University Hospital Midtown
Atlanta , Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta , Georgia
Emory Saint Joseph's Hospital
Atlanta , Georgia
Northside Hospital
Atlanta , Georgia
MultiCare Auburn Medical Center
Auburn , Washington
Hematology Oncology Associates of Central New York-Auburn
Auburn , New York
Sutter Auburn Faith Hospital
Auburn , California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn , California
Harold Alfond Center for Cancer Care
Augusta , Maine
Augusta University Medical Center
Augusta , Georgia
Rush-Copley Medical Center
Aurora , Illinois
Advocate Outpatient Center - Aurora
Aurora , Illinois
Rocky Mountain Cancer Centers-Aurora
Aurora , Colorado
The Medical Center of Aurora
Aurora , Colorado
Rocky Mountain Regional VA Medical Center
Aurora , Colorado
UCHealth University of Colorado Hospital
Aurora , Colorado
Dell Seton Medical Center at The University of Texas
Austin , Texas
University of Texas at Austin
Austin , Texas
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura , Florida
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island , Washington
Saint Alphonsus Cancer Care Center-Baker City
Baker City , Oregon
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield , California
Kaiser Permanente-Baldwin Park
Baldwin Park , California
University of Maryland/Greenebaum Cancer Center
Baltimore , Maryland
Greater Baltimore Medical Center
Baltimore , Maryland
Sinai Hospital of Baltimore
Baltimore , Maryland
MedStar Union Memorial Hospital
Baltimore , Maryland
MedStar Harbor Hospital
Baltimore , Maryland
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore , Maryland
Kaiser Permanente-Woodlawn Medical Center
Baltimore , Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore , Maryland
Eastern Maine Medical Center
Bangor , Maine
Flaget Memorial Hospital
Bardstown , Kentucky
Advocate Good Shepherd Hospital
Barrington , Illinois
Memorial Sloan Kettering Basking Ridge
Basking Ridge , New Jersey
LSU Health Baton Rouge-North Clinic
Baton Rouge , Louisiana
Our Lady of the Lake Physician Group
Baton Rouge , Louisiana
Our Lady of The Lake
Baton Rouge , Louisiana
Louisiana Hematology Oncology Associates LLC
Baton Rouge , Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge , Louisiana
Ochsner Health Center-Summa
Baton Rouge , Louisiana
Medical Center of Baton Rouge
Baton Rouge , Louisiana
Ochsner High Grove
Baton Rouge , Louisiana
Bronson Battle Creek
Battle Creek , Michigan
Essentia Health - Baxter Clinic
Baxter , Minnesota
Northwell Health Imbert Cancer Center
Bay Shore , New York
Houston Methodist San Jacinto Hospital
Baytown , Texas
UHHS-Chagrin Highlands Medical Center
Beachwood , Ohio
UPMC-Heritage Valley Health System Beaver
Beaver , Pennsylvania
Indu and Raj Soin Medical Center
Beavercreek , Ohio
UM Upper Chesapeake Medical Center
Bel Air , Maryland
MaineHealth Waldo Hospital
Belfast , Maine
Nebraska Medicine-Bellevue
Bellevue , Nebraska
Overlake Medical Center
Bellevue , Washington
Kaiser Permanente-Bellflower
Bellflower , California
PeaceHealth Saint Joseph Medical Center
Bellingham , Washington
Gaston Hematology and Oncology Associates-Belmont
Belmont , North Carolina
Strecker Cancer Center-Belpre
Belpre , Ohio
Sanford Joe Lueken Cancer Center
Bemidji , Minnesota
Saint Charles Health System
Bend , Oregon
Southwestern Vermont Medical Center
Bennington , Vermont
Alta Bates Summit Medical Center-Herrick Campus
Berkeley , California
ThedaCare Cancer Care - Berlin
Berlin , Wisconsin
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners , Vermont
Walter Reed National Military Medical Center
Bethesda , Maryland
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem , Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem , Pennsylvania
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf , Iowa
Beverly Hospital
Beverly , Massachusetts
MaineHealth Maine Medical Center - Biddeford
Biddeford , Maine
Billings Clinic Cancer Center
Billings , Montana
Saint Vincent Healthcare
Billings , Montana
Saint Vincent Frontier Cancer Center
Billings , Montana
Lourdes Hospital
Binghamton , New York
University of Alabama at Birmingham Cancer Center
Birmingham , Alabama
Sanford Bismarck Medical Center
Bismarck , North Dakota
OSF Saint Joseph Medical Center
Bloomington , Illinois
Illinois CancerCare-Bloomington
Bloomington , Illinois
Saint Joseph's/Candler - Bluffton Campus
Bluffton , South Carolina
Saint Elizabeth Boardman Hospital
Boardman , Ohio
Boca Raton Regional Hospital
Boca Raton , Florida
Prisma Health Cancer Institute - Spartanburg
Boiling Springs , South Carolina
Saint Alphonsus Cancer Care Center-Boise
Boise , Idaho
Saint Luke's Cancer Institute - Boise
Boise , Idaho
Central Care Cancer Center - Bolivar
Bolivar , Missouri
Parkland Health Center-Bonne Terre
Bonne Terre , Missouri
McFarland Clinic - Boone
Boone , Iowa
Massachusetts General Hospital Cancer Center
Boston , Massachusetts
Brigham and Women's Hospital
Boston , Massachusetts
Boston Medical Center
Boston , Massachusetts
Beth Israel Deaconess Medical Center
Boston , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
Boulder Community Foothills Hospital
Boulder , Colorado
Rocky Mountain Cancer Centers-Boulder
Boulder , Colorado
Bozeman Health Deaconess Hospital
Bozeman , Montana
Essentia Health Saint Joseph's Medical Center
Brainerd , Minnesota
Cox Cancer Center Branson
Branson , Missouri
Northeast Georgia Medical Center Braselton
Braselton , Georgia
Lafayette Family Cancer Center-EMMC
Brewer , Maine
Ocean University Medical Center
Brick , New Jersey
United Hospital Center
Bridgeport , West Virginia
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton , Massachusetts
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton , Michigan
Trinity Health Medical Center - Brighton
Brighton , Michigan
Bristol Regional Medical Center
Bristol , Tennessee
Wellmont Medical Associates Oncology and Hematology-Bristol
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