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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04268550
Other study ID # S1900B
Secondary ID NCI-2019-08097S1
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 8, 2020
Est. completion date January 1, 2025

Study information

Verified date December 2023
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer that is stage IV or has come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Description:

PRIMARY OBJECTIVE: I. To evaluate the objective response rate (ORR) (confirmed complete or partial response) by blinded independent centralized review (BICR) associated with selpercatinib (LOXO-292) in patients with previously-treated stage IV or recurrent RET fusion-positive non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate the duration of BICR-assessed response among BICR responders. II. To evaluate the frequency and severity of toxicities. III. To evaluate the investigator-assessed objective response rate (confirmed complete or partial response). IV. To evaluate duration of investigator-assessed response among patients with a response as determined by the local investigator. V. To evaluate investigator-assessed progression-free survival (IA-PFS). VI. To evaluate BICR-assessed PFS. VII. To evaluate overall survival (OS). VIII. Among patients with brain metastases at baseline: VIIIa. To evaluate the central nervous system (CNS) response rate (confirmed complete response [CR]). VIIIb. To evaluate the duration of intracranial response among patients with a CNS response. TRANSLATIONAL MEDICINE OBJECTIVES: I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA). II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC). OUTLINE: Patients receive selpercatinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of 3 years from date of sub-study registration.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 124
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC as defined here: - Patients must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay, other tumor-based assays such as next-generation sequencing (NGS), polymerase chain reaction (PCR), or follicular in situ hybridization (FISH), or by cfDNA blood assay. Patients with RET fusions detected by immunohistochemistry (IHC) alone are not eligible. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Presence of RET fusions detected on tests performed outside of LUNGMAP must have been confirmed by the study biomarker review panel - For patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen. For patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g. nivolumab, pembrolizumab, or durvalumab) is allowed - Patients must be negative for all additional validated oncogenic drivers that could cause resistance to LOXO-292 treatment. This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-level amplification and expression - Note: EGFR, ALK, ROS, KRAS, and BRAF testing is performed as part of the LUNGMAP screening/pre-screening FoundationOne test. If prior data is not available, results from the FMI testing must be obtained prior to sub-study registration - Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration. CT and MRI scans must be submitted for central review via transfer of images and data (TRIAD) - Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration - Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration - Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration - Patients must be able to swallow capsules - Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy - Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration - Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration) - Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration) - Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study registration) (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, bilirubin and either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN) - Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula (within 28 days prior to sub-study registration) - Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration - Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years - Patients must have electrolytes and blood urea nitrogen (BUN) performed within 14 days prior to sub-study registration - Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) Exclusion Criteria: - Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted) - Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration - Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to sub-study registration - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable - Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator - Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia - Patients must not have a QT interval by Fridericia (QTcF) > 470 msec based on the electrocardiogram (ECG) within 28 days prior to registration. It is suggested that a local cardiologist review the QTcF intervals - Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled infection, requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus - Uncontrolled diabetes: Patients who have a diagnosis of diabetes must have an hemoglobin (Hb) A1C < 7% within 28 days prior to registration. The same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months - Uncontrolled blood pressure and hypertension: All blood pressure measurements within the 28 days prior to registration must be systolic blood pressure (SBP) =< 180 and diastolic blood pressure (DBP) =< 100. An exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a blood pressure within the parameters above - Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LOXO-292 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease) - Patients must not be planning to receive any strong inhibitors or inducers of CYP3A4 at least 14 days prior to sub-study registration and throughout protocol treatment - Patients must not be planning to use proton pump inhibitors (PPIs) at least one week prior to sub-study registration and throughout protocol treatment - Patients must not be pregnant or nursing. Women study patients of reproductive potential and fertile men study patients and their partners must abstain or use effective contraception (including barrier method) while receiving study treatment and for at least 3 months after the last dose of LOXO-292. Male study patients must agree not to donate sperm for 6 months after the last dose of LOXO-292. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

Study Design


Intervention

Drug:
Selpercatinib
Given PO

Locations

Country Name City State
United States Hawaii Cancer Care - Savio 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States New Mexico Oncology Hematology Consultants Albuquerque New Mexico
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic PC - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Kaiser Permanente-Anaheim Anaheim California
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Randolph Hospital Asheboro North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northside Hospital Atlanta Georgia
United States Sutter Auburn Faith Hospital Auburn California
United States Harold Alfond Center for Cancer Care Augusta Maine
United States University of Colorado Hospital Aurora Colorado
United States Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner High Grove Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States Waldo County General Hospital Belfast Maine
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States McFarland Clinic PC-Boone Boone Iowa
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Deaconess Hospital Bozeman Montana
United States Northeast Georgia Medical Center Braselton Braselton Georgia
United States IHA Hematology Oncology Consultants-Brighton Brighton Michigan
United States Saint Joseph Mercy Brighton Brighton Michigan
United States James J Peters VA Medical Center Bronx New York
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States IHA Hematology Oncology Consultants-Canton Canton Michigan
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rex Hematology Oncology Associates-Cary Cary North Carolina
United States Geauga Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Northwestern University Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Case Western Reserve University Cleveland Ohio
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Memorial Hospital North Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Mary Imogene Bassett Hospital Cooperstown New York
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Western Maryland Regional Medical Center Cumberland Maryland
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Genesis Cancer Care Institute Davenport Iowa
United States Genesis Medical Center - East Campus Davenport Iowa
United States Iowa Cancer Specialists Davenport Iowa
United States Atlanta VA Medical Center Decatur Georgia
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Henry Ford Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Bayhealth Hospital Kent Campus Dover Delaware
United States Essentia Health Cancer Center Duluth Minnesota
United States Northside Hospital - Duluth Duluth Georgia
United States Durham VA Medical Center Durham North Carolina
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton Pennsylvania
United States Crossroads Cancer Center Effingham Illinois
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Kaiser Permanente-Fontana Fontana California
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa
United States Parkview Regional Medical Center Fort Wayne Indiana
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Rex Hematology Oncology Associates-Garner Garner North Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Adams Cancer Center Gettysburg Pennsylvania
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Goshen Center for Cancer Care Goshen Indiana
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States UCHealth Greeley Hospital Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Kaiser Permanente - Harbor City Harbor City California
United States UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania
United States Hartford Hospital Hartford Connecticut
United States HaysMed University of Kansas Health System Hays Kansas
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Kaiser Permanente-Irvine Irvine California
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States McFarland Clinic PC-Jefferson Jefferson Iowa
United States West Michigan Cancer Center Kalamazoo Michigan
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States Ochsner Medical Center Kenner Kenner Louisiana
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Sparrow Hospital Lansing Michigan
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at Oakey Las Vegas Nevada
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Sechler Family Cancer Center Lebanon Pennsylvania
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Saint Mary Mercy Hospital Livonia Michigan
United States Loma Linda University Medical Center Loma Linda California
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States UCHealth Lone Tree Health Center Lone Tree Colorado
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente-Cadillac Los Angeles California
United States McKee Medical Center Loveland Colorado
United States Medical Center of the Rockies Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States McFarland Clinic PC-Marshalltown Marshalltown Iowa
United States UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Aspirus Medford Hospital Medford Wisconsin
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Mount Sinai Medical Center Miami Beach Florida
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Bayhealth Hospital Sussex Campus Milford Delaware
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Virtua Samson Cancer Center Moorestown New Jersey
United States Franciscan Health Mooresville Mooresville Indiana
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Licking Memorial Hospital Newark Ohio
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Kaiser Permanente-Ontario Ontario California
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States University Hospitals Parma Medical Center Parma Ohio
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Jefferson Healthcare Port Townsend Washington
United States Kaiser Permanente Northwest Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Pottstown Hospital Pottstown Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rex Cancer Center Raleigh North Carolina
United States Rex Cancer Center of Wakefield Raleigh North Carolina
United States Rex Hematology Oncology Associates-Blue Ridge Raleigh North Carolina
United States University Hospitals Portage Medical Center Ravenna Ohio
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Renown Regional Medical Center Reno Nevada
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho New Mexico
United States Kaiser Permanente-Riverside Riverside California
United States University of Rochester Rochester New York
United States Penobscot Bay Medical Center Rockport Maine
United States Sutter Roseville Medical Center Roseville California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salem Hospital Salem Oregon
United States Salina Regional Health Center Salina Kansas
United States Kaiser Permanente-San Diego Zion San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Marcos San Marcos California
United States Essentia Health Sandstone Sandstone Minnesota
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Genesis Cancer Center - Silvis Silvis Illinois
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Suburban Hematology Oncology Associates - Snellville Snellville Georgia
United States Memorial Hospital of South Bend South Bend Indiana
United States Maine Medical Partners - South Portland South Portland Maine
United States Prisma Health Cancer Institute - Spartanburg Spartanburg South Carolina
United States Mercy Hospital Springfield Springfield Missouri
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States ProMedica Flower Hospital Sylvania Ohio
United States Moffitt Cancer Center Tampa Florida
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Virtua Voorhees Voorhees New Jersey
United States University Hospitals Sharon Health Center Wadsworth Ohio
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 Mercy Medical Center-West Lakes West Des Moines Iowa
United States Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States Presbyterian Intercommunity Hospital Whittier California
United States UPMC Susquehanna Williamsport Pennsylvania
United States Aspirus UW Cancer Center Wisconsin Rapids Wisconsin
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Metro Health Hospital Wyoming Michigan
United States WellSpan Health-York Cancer Center York Pennsylvania
United States IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate by blinded independent centralized review (BICR) A response will be confirmed by a complete response (CR) or partial response (PR). Proportions and associated confidence intervals will be calculated. Up to 3 years from date of sub-study registration
Secondary Incidence of adverse events Will be assessed using Common Terminology Criteria for Adverse Event version 5.0. Up to 3 years from date of sub-study registration
Secondary BICR-progression-free survival (PFS) Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times From date of sub-study registration to date of first documentation of progression assessed by BICR or symptomatic deterioration, or death due to any cause, assessed up to 3 years from date of sub-study registration
Secondary Investigator-assessed (IA) PFS Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years from date of sub-study registration
Secondary Overall survival Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times Up to 3 years from date of sub-study registration
Secondary BICR-duration of response (DOR) Will be evaluated among patients who achieve a confirmed response. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times. The median DOR and percentage with DOR at landmark times at 6 and 12 months after documentation of confirmed response will be estimated. From date of first documentation of confirmed response (CR or PR) to date of first documentation of progression assessed by BICR or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months
Secondary Central nervous system (CNS) response rate Will be assessed among patients with brain metastases. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times Baseline
Secondary Duration of intracranial response among patients with a CNS response Will be assessed among patients with brain metastases. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times Baseline
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