Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

NCT ID: NCT03137771

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-07
• Study Completion Date: 2028-12-31

Brief Summary

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Detailed Description

PRIMARY OBJECTIVES:

Phase II

To evaluate the impact of adding local consolidative therapy (LCT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy.

Phase III

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure.

II. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions.

III. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity.

IV. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage.

V. To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL).

VI. To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA).

Patients are randomized 2:1 between the SBRT and chemotherapy vs. chemotherapy alone arms.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

Conditions

Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 (systemic maintenance chemotherapy)

Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

Erlotinib Hydrochloride

Intervention Type: DRUG

Given PO

Pembrolizumab

Intervention Type: DRUG

Given IV

Docetaxel

Intervention Type: DRUG

Given IV

Gemcitabine

Intervention Type: DRUG

Given IV

Pemetrexed Disodium

Intervention Type: DRUG

Given IV

Arm 2 (LCT + systemic maintenance chemotherapy)

Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3D-CRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

Undergo SBRT

Erlotinib Hydrochloride

Intervention Type: DRUG

Given PO

Pembrolizumab

Intervention Type: DRUG

Given IV

3-Dimensional Conformal Radiation Therapy (3D-CRT)

Intervention Type: RADIATION

Undergo 3DCRT

Docetaxel

Intervention Type: DRUG

Given IV

Gemcitabine

Intervention Type: DRUG

Given IV

Intensity-Modulated Radiation Therapy (IMRT)

Intervention Type: RADIATION

Undergo IMRT

Pemetrexed Disodium

Intervention Type: DRUG

Given IV

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Undergo SBRT

Intervention Type: RADIATION

Erlotinib Hydrochloride

Given PO

Intervention Type: DRUG

Pembrolizumab

Given IV

Intervention Type: DRUG

3-Dimensional Conformal Radiation Therapy (3D-CRT)

Undergo 3DCRT

Intervention Type: RADIATION

Docetaxel

Given IV

Intervention Type: DRUG

Gemcitabine

Given IV

Intervention Type: DRUG

Intensity-Modulated Radiation Therapy (IMRT)

Undergo IMRT

Intervention Type: RADIATION

Pemetrexed Disodium

Given IV

Intervention Type: DRUG

Other Intervention Names

3-dimensional conformal radiation therapy; 3-dimensional radiation therapy; 3D CONFORMAL RADIATION THERAPY; 3D CRT; 3D-CRT; Conformal Therapy; Radiation Conformal Therapy; Docecad; RP56976; Taxotere; Taxotere Injection Concentrate; dFdC; dFdCyd; Difluorodeoxycytidine; IMRT; Intensity Modulated RT; INTENSITY-MODULATED RADIATION THERAPY; Intensity-Modulated Radiotherapy; Alimta; LY231514; N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt; SBRT; stereotactic body radiation therapy; Tarceva; Keytruda

Eligibility Criteria

Inclusion Criteria

• Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
• Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trial and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child.
• Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop limited metastases. Limited metastases is defined as 3 or fewer sites of metastatic disease
• Appropriate stage for study entry based on the following diagnostic workup:

• History/physical examination by a radiation oncologist (and a surgeon if surgery is planned) within 30 days prior to registration
• Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least diagnostic quality CT chest through the adrenals or positron emission tomography (PET)/CT within 30 days prior to registration
• Zubrod performance status 0, 1, or 2 within 30 days prior to registration
• Adequate organ and hematologic/bone marrow function within 14 days prior to registration, defined as follows:

• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease
• Total bilirubin ≤ 1.5 × ULN
• Absolute neutrophil count (ANC) ≥ 500 cells/mm3
• Platelets ≥ 50,000 cells/mm3
• Renal:
• Creatinine ≤ 1.5 x ULN; or
• Creatinine Clearance (CrCl) > 45 mL/min if creatinine > 1.5 x ULN (calculated CrCl based on Cockcroft-Gault equation)
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For patients who will undergo resection of disease (if randomized to Arm 2 and dispositioned to receive surgery), adequate pre-surgical work-up for anticipated surgery, as defined by institutional guidelines.
• Negative serum pregnancy test within one week prior to registration for females of childbearing potential
• Patients must have received first-line/induction systemic therapy comprising of immunotherapy and/or platinum-based chemotherapy (at least 4 cycles or courses but less than 6, i.e. 4-5 cycles/courses), and achieved stable disease or a partial response. Though the intention is for every course/cycle to be identical in an induction regimen, Some but not all of the 4-5 cycles may omit an immunotherapy or platinum compound if the treating physician determines it is in the patient's best interest secondary to toxicity or other institutional parameter.
• For patients treated with nivolumab, ipilimumab and 2 cycles of chemotherapy, the 4-5 cycles requirement will be met by 4-5 total doses of nivolumab.
• For patients treated with nivolumab and ipilimumab, this requirement will be met by 2 doses of ipilimumab and 4-5 doses of nivolumab.
• After induction systemic therapy, patients must have a minimum of one site of disease, primary or metastasis, present for potential consolidation with local therapy. All sites of disease present after induction systemic therapy, primary and metastases (up to 3) are able to be consolidated with local therapy;
• Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage I-III NSCLC, adjuvant or neo-adjuvant therapy for stage I-III NSCLC, as adjuvant therapy for previously resected or irradiated NSCLC, or for other previous cancers is permitted
• For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation. If the primary disease is found in the peripheral or central lung parenchyma without nodal disease, for instance, SBRT may be employed at the discretion of the treating institution. If primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation; surgery should only be used for metastatic tumors that can be completely resected by lobectomy, segmentectomy, or wide wedge resection.
• If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy.
• The patient or a legally authorized representative must provide study-specific informed consent prior to registration.
• Radiotherapy for patients with brain metastases prior to registration is acceptable.
• Patients with brain metastases are eligible if these lesions have been previously treated or resolved and the patients have no clinical or radiographic evidence of progression prior to registration.
• Subjects may receive palliative radiotherapy for symptomatic metastases or primary disease prior to registration provided that there is at least one other non-irradiated lesion amenable to LCT at the time of registration.

Exclusion Criteria

• Clinical or radiologic evidence of untreated and/or progressive brain metastases prior to registration after induction systemic therapy
• Cutaneous metastasis of NSCLC
• Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions
• Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
• Metastases located within 3 cm of previously irradiated (< 3 Gy per fraction) structures if if not a candidate for surgery for these lesions and if:

• Spinal cord previously irradiated to > 40 Gy
• Brachial plexus previously irradiated to > 50 Gy
• Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
• Brainstem previously irradiated to > 50 Gy
• Lung previously irradiated with prior V20 Gy > 35%
• Patients receiving targeted therapy (non-cytotoxic systemic therapy) for NSCLC in the first-line setting
• Patients with NSCLC who have driver mutations for which targeted therapies (non-cytotoxic, non-immunotherapy based systemic therapy including but not limited to tyrosine-kinase inhibitors) are available. Such designations would include but not be limited to treatments targeting epidermal growth factor receptor (EGFR) mutant or anaplastic lymphoma kinase (ALK) positive NSCLC.
• If a patient has progressed in previous areas of primary disease that received definitive doses of radiation, these patients would require re-irradiation in previous high dose anatomic areas and are not eligible for this study.
• Patients with malignant pleural effusions that do not resolve after first-line systemic therapy; patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line systemic therapy
• Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 radiation/surgery plans to cover these distinct metastatic disease entities
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 180 days after the completion of all treatment. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding (and unwilling to discontinue) are also excluded
• Participation in any investigational drug study for the treatment of cancer within 4 weeks prior to registration.
• For patients who received immunotherapy during induction, patients on chronic steroids or who have active autoimmune disease for which they received systemic treatment in the previous 2 years with corticosteroids, disease modifying agents, or immunosuppressive drugs are not eligible. Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is allowed. Patients with active interstitial lung disease or who have a history of pneumonitis for which they had received glucocorticoids are not eligible
• Use of bevacizumab or other antiangiogenic therapy in first-line or planned maintenance therapy (due to potential for increased complications from local therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Puneeth Iyengar

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Memorial Medical Center

Modesto, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Salinas Valley Memorial

Salinas, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Yale University

New Haven, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Tallahassee Memorial HealthCare

Tallahassee, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Cleveland Clinic-Weston

Weston, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Edward Hines Jr VA Hospital

Hines, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Goshen Center for Cancer Care

Goshen, Indiana, United States

Community Cancer Center East

Indianapolis, Indiana, United States

Community Cancer Center South

Indianapolis, Indiana, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Community Cancer Center North

Indianapolis, Indiana, United States

Franciscan Health Mooresville

Mooresville, Indiana, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Saint Elizabeth Healthcare Edgewood

Edgewood, Kentucky, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Norton Brownsboro Hospital and Medical Campus

Louisville, Kentucky, United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

TidalHealth Richard A Henson Cancer Institute

Ocean Pines, Maryland, United States

TidalHealth Peninsula Regional

Salisbury, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Singh and Arora Hematology Oncology PC

Flint, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Mid-Michigan Physicians-Lansing

Lansing, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

McLaren-Port Huron

Port Huron, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Henry Ford Health Warren Hospital

Warren, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Wentworth-Douglass Hospital

Dover, New Hampshire, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Virtua Samson Cancer Center

Moorestown, New Jersey, United States

Virtua Memorial

Mount Holly, New Jersey, United States

Community Medical Center

Toms River, New Jersey, United States

Virtua Voorhees

Voorhees Township, New Jersey, United States

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Lovelace Radiation Oncology

Albuquerque, New Mexico, United States

Christus Saint Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

East White Plains, New York, United States

Mount Sinai West

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Dickstein Cancer Treatment Center

White Plains, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, United States

Atrium Health University City/LCI-University

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Atrium Health Union/LCI-Union

Monroe, North Carolina, United States

CarolinaEast Medical Center

New Bern, North Carolina, United States

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, United States

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Altru Cancer Center

Grand Forks, North Dakota, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Geauga Hospital

Chardon, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

University Hospitals Parma Medical Center

Parma, Ohio, United States

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

North Coast Cancer Care

Sandusky, Ohio, United States

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

ProMedica Flower Hospital

Sylvania, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, United States

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Good Samaritan Hospital

Corvallis, Oregon, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, United States

Saint Vincent Hospital

Erie, Pennsylvania, United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Lancaster General Ann B Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Lewistown Hospital

Lewistown, Pennsylvania, United States

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

Reading Hospital

West Reading, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Self Regional Healthcare

Greenwood, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

The Radiation Oncology Center-Hilton Head/Bluffton

Hilton Head Island, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

Covenant Medical Center-Lakeside

Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

George E Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

West Virginia University Healthcare

Morgantown, West Virginia, United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Ascension Saint Elizabeth Hospital

Appleton, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Aurora Health Center-Fond du Lac

Fond du Lac, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Ascension Mercy Hospital

Oshkosh, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

London Regional Cancer Program

London, Ontario, Canada

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

King Faisal Specialist Hospital and Research Centre

Riyadh, , Saudi Arabia

Countries

United States; Canada; Israel; Saudi Arabia

References

Mattes MD, Eubank TD, Almubarak M, Wen S, Marano GD, Jacobson GM, Ma PC. A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer. Clin Lung Cancer. 2021 Jul;22(4):268-273. doi: 10.1016/j.cllc.2021.01.012. Epub 2021 Jan 25.

Reference Type: DERIVED

PMID: 33608212 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2016-00849

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-LU002

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-LU002

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NRG-LU002

Identifier Type: -

Identifier Source: org_study_id