RECRUITING

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Conditions

Advanced Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Lung Non-Small Cell Cancer AJCC v7

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Official Title

Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

Quick Facts

Study Start:2018-04-25

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03191149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) * Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria * An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay * NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports * Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration * Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed * Participants must not have previously received osimertinib * Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Hemoglobin \>= 9.0 g/L (within 4 weeks before registration) * Leukocytes/white blood cells \>= 3,000/mcL (within 4 weeks before registration) * Absolute neutrophil count \>= 1,500/mcL (within 4 weeks before registration) * Platelets \>= 100,000/mcL (within 4 weeks before registration) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) if no liver metastases or =\< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal; for patients with known hepatic metastases AST and/or ALT =\< 5 x ULN (within 4 weeks before registration) * Creatinine =\< 1.5 x institutional upper limit of normal (within 4 weeks before registration) * Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis * Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to central nervous system (CNS) lesions, osimertinib can be held on the day of radiation only. For palliative radiotherapy (RT) to other sites of disease outside of the thorax osimertinib (osi) should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the investigator's discretion with the approval of the study principal investigator (PI). For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized adverse events (AEs) following the procedure * Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic * Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \>= 50% for the patient to be eligible * Participants may not have any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \>= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value * No history of QT prolongation associated with other medications that required discontinuation of that medication * Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: serum/plasma potassium \< LLN; serum/plasma magnesium \< LLN; serum/plasma calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval * Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV * Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed * Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment * Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291) * Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4 * If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) or P-glycoprotein (Pgp) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib (AZD9291) * NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use * If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 \[osimertinib\]) should be as low as possible and should be guided by the statin label. Monitoring of low-density lipoprotein (LDL) cholesterol levels is advised. If the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken * Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR) * No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy * Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib (AZD9291) are ineligible * Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study. WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug. Sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug * Other anticancer agents and investigational agents should not be given while the subject is on study treatment * Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator * A guidance regarding potential interactions with concomitant medications is provided	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria
* An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay
* NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
* Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
* Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
* Participants must not have previously received osimertinib
* Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Hemoglobin \>= 9.0 g/L (within 4 weeks before registration)
* Leukocytes/white blood cells \>= 3,000/mcL (within 4 weeks before registration)
* Absolute neutrophil count \>= 1,500/mcL (within 4 weeks before registration)
* Platelets \>= 100,000/mcL (within 4 weeks before registration)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) if no liver metastases or =\< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal; for patients with known hepatic metastases AST and/or ALT =\< 5 x ULN (within 4 weeks before registration)
* Creatinine =\< 1.5 x institutional upper limit of normal (within 4 weeks before registration)
* Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis
* Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to central nervous system (CNS) lesions, osimertinib can be held on the day of radiation only. For palliative radiotherapy (RT) to other sites of disease outside of the thorax osimertinib (osi) should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the investigator's discretion with the approval of the study principal investigator (PI). For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized adverse events (AEs) following the procedure
* Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic
* Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \>= 50% for the patient to be eligible
* Participants may not have any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) \>= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value
* No history of QT prolongation associated with other medications that required discontinuation of that medication
* Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: serum/plasma potassium \< LLN; serum/plasma magnesium \< LLN; serum/plasma calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
* Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV
* Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed
* Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment
* Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)
* Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
* If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) or P-glycoprotein (Pgp) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib (AZD9291)
* NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use
* If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 \[osimertinib\]) should be as low as possible and should be guided by the statin label. Monitoring of low-density lipoprotein (LDL) cholesterol levels is advised. If the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken
* Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR)
* No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy
* Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib (AZD9291) are ineligible
* Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study. WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug. Sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug
* Other anticancer agents and investigational agents should not be given while the subject is on study treatment
* Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator
* A guidance regarding potential interactions with concomitant medications is provided

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Zofia Piotrowska

PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508

United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504

United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508

United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508

United States

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

United States

Anchorage Oncology Centre

Anchorage, Alaska, 99508

United States

Katmai Oncology Group

Anchorage, Alaska, 99508

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

United States

CARTI Cancer Center

Little Rock, Arkansas, 72205

United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Holy Cross Hospital

Fort Lauderdale, Florida, 33308

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Walter Knox Memorial Hospital

Emmett, Idaho, 83617

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

OSF Saint Anthony's Health Center

Alton, Illinois, 62002

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

United States

SIH Cancer Institute

Carterville, Illinois, 62918

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Saint Mary's Hospital

Centralia, Illinois, 62801

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Valley Radiation Oncology

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

North Shore Medical Center

Skokie, Illinois, 60076

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Southwest Illinois Health Services LLP

Swansea, Illinois, 62226

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560

United States

Midwestern Regional Medical Center

Zion, Illinois, 60099

United States

Reid Health

Richmond, Indiana, 47374

United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, 51503

United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, 51503

United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ

Council Bluffs, Iowa, 51503

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Iowa Lutheran Hospital

Des Moines, Iowa, 50316

United States

Trinity Regional Medical Center

Fort Dodge, Iowa, 50501

United States

Methodist West Hospital

West Des Moines, Iowa, 50266-7700

United States

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530

United States

Ochsner Health Center-Summa

Baton Rouge, Louisiana, 70809

United States

Medical Center of Baton Rouge

Baton Rouge, Louisiana, 70816

United States

Ochsner High Grove

Baton Rouge, Louisiana, 70836

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

Baltimore, Maryland, 21237

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Mercy Medical Center

Springfield, Massachusetts, 01104

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Caro Cancer Center

Caro, Michigan, 48723

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346

United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346

United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

United States

Henry Ford River District Hospital

East China Township, Michigan, 48054

United States

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, 48236

United States

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, 48236

United States

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, 48236

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Ascension Borgess Cancer Center

Kalamazoo, Michigan, 49009

United States

Ascension Borgess Hospital

Kalamazoo, Michigan, 49048

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Hope Cancer Clinic

Livonia, Michigan, 48154

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, 48044

United States

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, 48453

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Henry Ford Health Providence Novi Hospital

Novi, Michigan, 48374

United States

Hope Cancer Center

Pontiac, Michigan, 48341

United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341

United States

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

United States

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, 48309

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085

United States

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075

United States

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, 48312

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

Advanced Breast Care Center PLLC

Warren, Michigan, 48088

United States

Henry Ford Health Warren Hospital

Warren, Michigan, 48093

United States

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, 48093

United States

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093

United States

Macomb Hematology Oncology PC

Warren, Michigan, 48093

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Fairview Ridges Hospital

Burnsville, Minnesota, 55337

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Cambridge Medical Center

Cambridge, Minnesota, 55008

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Unity Hospital

Fridley, Minnesota, 55432

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Health Partners Inc

Minneapolis, Minnesota, 55454

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

New Ulm Medical Center

New Ulm, Minnesota, 56073

United States

Fairview Northland Medical Center

Princeton, Minnesota, 55371

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Ridgeview Medical Center

Waconia, Minnesota, 55387

United States

Rice Memorial Hospital

Willmar, Minnesota, 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092

United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

United States

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628

United States

Cox Cancer Center Branson

Branson, Missouri, 65616

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Southeast Cancer Center

Cape Girardeau, Missouri, 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

United States

Freeman Health System

Joplin, Missouri, 64804

United States

Mercy Hospital Joplin

Joplin, Missouri, 64804

United States

Lake Regional Hospital

Osage Beach, Missouri, 65065

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

United States

Saint Louis Cancer and Breast Institute-South City

Saint Louis, Missouri, 63109

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Mercy Hospital Washington

Washington, Missouri, 63090

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Great Falls Clinic

Great Falls, Montana, 59405

United States

Saint Peter's Community Hospital

Helena, Montana, 59601

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, 68114

United States

Nebraska Methodist Hospital

Omaha, Nebraska, 68114

United States

Oncology Associates PC

Omaha, Nebraska, 68114

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Garnet Health Medical Center

Middletown, New York, 10940

United States

Dickstein Cancer Treatment Center

White Plains, New York, 10601

United States

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791

United States

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431

United States

Saint Elizabeth Boardman Hospital

Boardman, Ohio, 44512

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, 45236

United States

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Armes Family Cancer Center

Findlay, Ohio, 45840

United States

Blanchard Valley Hospital

Findlay, Ohio, 45840

United States

Orion Cancer Care

Findlay, Ohio, 45840

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Dayton Physicians LLC-Wayne

Greenville, Ohio, 45331

United States

Wayne Hospital

Greenville, Ohio, 45331

United States

Greater Dayton Cancer Center

Kettering, Ohio, 45409

United States

First Dayton Cancer Care

Kettering, Ohio, 45420

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Springfield Regional Cancer Center

Springfield, Ohio, 45504

United States

Springfield Regional Medical Center

Springfield, Ohio, 45504

United States

Dayton Physicians LLC - Troy

Troy, Ohio, 45373

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

Saint Joseph Warren Hospital

Warren, Ohio, 44484

United States

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

United States

Saint Alphonsus Cancer Care Center-Baker City

Baker City, Oregon, 97814

United States

Saint Charles Health System

Bend, Oregon, 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

United States

Bay Area Hospital

Coos Bay, Oregon, 97420

United States

Good Samaritan Hospital

Corvallis, Oregon, 97330

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Saint Charles Health System-Redmond

Redmond, Oregon, 97756

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

Main Line Health Center-Collegeville

Collegeville, Pennsylvania, 19426

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

United States

Main Line Health Center-Exton

Exton, Pennsylvania, 19341

United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201

United States

Riddle Memorial Hospital

Media, Pennsylvania, 19063

United States

Bryn Mawr Health Center

Newtown Square, Pennsylvania, 19073

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

Penn State Health Saint Joseph Medical Center

Reading, Pennsylvania, 19605

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225

United States

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Providence Regional Cancer Partnership

Everett, Washington, 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington, 98632

United States

Pacific Gynecology Specialists

Seattle, Washington, 98104

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Kaiser Permanente Washington

Seattle, Washington, 98112

United States

Swedish Medical Center-Cherry Hill

Seattle, Washington, 98122-5711

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

University of Washington Medical Center - Montlake

Seattle, Washington, 98195

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284

United States

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362

United States

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, 54729

United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Aurora Health Center-Fond du Lac

Fond Du Lac, Wisconsin, 54937

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

Marshfield Medical Center - Ladysmith

Ladysmith, Wisconsin, 54848

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494

United States

Billings Clinic-Cody

Cody, Wyoming, 82414

United States

Welch Cancer Center

Sheridan, Wyoming, 82801

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Zofia Piotrowska, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-25

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2018-04-25

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Advanced Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Lung Non-Small Cell Cancer AJCC v7