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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02186847
Other study ID # NRG-LU001
Secondary ID NCI-2014-01071PN
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 2014
Est. completion date April 16, 2025

Study information

Verified date June 2023
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.


Description:

PRIMARY OBJECTIVES: I. To determine whether metformin hydrochloride (MET) added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM). II. Evaluate the effect of MET on chemoradiotherapy toxicity (Common Terminology Criteria for Adverse Events, version 4 [CTCAE, v. 4]) within 1 year of completion of all treatment. III. Collect biospecimens to develop biomarkers of MET activity. OUTLINE: Patients are randomized to 1 of 2 treatment arms. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 170
Est. completion date April 16, 2025
Est. primary completion date April 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified) - Patients must have measurable disease - Patients must have unresectable disease, be medically inoperable, or unwilling to undergo surgical management - Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: - History/physical examination, including documentation of height, weight, body surface area, and vital signs, within 30 days prior to registration - Computed tomography (CT) with IV contrast or magnetic resonance imaging (MRI) imaging (if CT scan with contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands, required within 45 days prior to registration (recommended within 30 days prior to registration - MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 45 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT; an MRI without contrast is only permitted if the patient has a contrast allergy - Whole-body fludeoxyglucose (FDG)-positron emission tomography (PET)/CT required within 45 days prior to registration (recommended within 30 days prior to registration; note: patients do not need to have a separate CT of the chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT with contrast - Zubrod performance status 0-1 - Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 - Complete blood count(CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: - Absolute neutrophil count (ANC) = 1,500 cells/mm3 - Platelets >= 100,000 cells/mm^3 - Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) - Adequate renal function within 14 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance must be at least 60 ml/min; - Adequate hepatic function within 14 days prior to registration, defined as total bilirubin = 1.5 x upper limit of normal (ULN) for the institution and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase = 2.5 x ULN for the institution; - Fasting blood glucose = 125 mg/dL within 14 days prior to registration; - Serum albumin > 3.0 g/dl within 14 days prior to registration; - For women of childbearing potential, a serum pregnancy test within 72 hours prior to registration; - Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration; - Patients must be at least 3 weeks from prior thoracotomy (if performed); - If a pleural effusion is present, the following criteria must be met at registration to exclude malignant involvement (incurable M1a disease): - When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; - Effusions that are minimal (i.e. not visible under ultrasound guidance) and that are too small to safely tap are eligible. - Women of childbearing potential and male participants must practice adequate contraception throughout the study; Exclusion Criteria: - Patients with mixed small cell and non-small cell histologies - Patients with distant metastasis - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Patients currently using metformin (metformin hydrochloride), other oral hypoglycemic agents or insulin - Patients with any history of allergic reaction to paclitaxel or other taxanes or carboplatin - Patients with a history of chronic kidney disease or lactic acidosis - Patients with >= 10% weight loss within the past month - Severe, active co-morbidity, defined as follows: - Diagnosis of type I or type II diabetes mellitus - Uncontrolled neuropathy >= grade 2 regardless of cause - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration - Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease - Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol - End-stage renal disease (ie, on dialysis or dialysis has been recommended) - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Radiation Therapy
Radiation therapy (RT) is given in 2 Gy fractions once daily 5 days per week to a total of 30 fractions and 60 Gy. Photons required; 3-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) permitted. Starts within 14 days of randomization (Chemoradiation arm) or 14 days after metformin starts (Chemoradiation + Metformin arm).
Drug:
Carboplatin
2 AUC (area under the curve) via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 6 AUC via IV starting 28-42 days after the end of radiation therapy.
Metformin
Metformin is taken orally. Dose escalation begins 2 weeks prior to the initiation of chemoradiation. 500 mg twice daily days 1-7 of metformin. 500 mg three times daily days 8-14 of metformin. Three times a day with the following dosage: 500mg in the morning, 1000mg at noon, and 500mg in the evening concurrent with chemoradiation and through consolidation chemotherapy (days 15-126 of metformin),
Paclitaxel
50 mg/m2 via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 200 mg/m2 via IV 28-42 days after the end of radiation therapy.

Locations

Country Name City State
Canada Jewish General Hospital Montreal Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Israel Chaim Sheba Medical Center Tel Hashomer
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Abington Memorial Hospital Abington Pennsylvania
United States New Mexico Oncology Hematology Consultants Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States AnMed Health Cancer Center Anderson South Carolina
United States Northwest Community Hospital Arlington Heights Illinois
United States Piedmont Hospital Atlanta Georgia
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States University of Colorado Hospital Aurora Colorado
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Gaston Hematology and Oncology Associates-Belmont Belmont North Carolina
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Billings Clinic Cancer Center Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States IU Health Bloomington Bloomington Indiana
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Boston Medical Center Boston Massachusetts
United States Harrison Medical Center Bremerton Washington
United States New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York
United States University of Vermont Medical Center Burlington Vermont
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Aultman Health Foundation Canton Ohio
United States Mercy Medical Center Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Eden Hospital Medical Center Castro Valley California
United States Mercy Hospital Cedar Rapids Iowa
United States Geauga Hospital Chardon Ohio
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States University of Cincinnati/Barrett Cancer 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 Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Mary Bird Perkins Cancer Center - Covington Covington Louisiana
United States Geisinger Medical Center Danville Pennsylvania
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Henry Ford Hospital Detroit Michigan
United States Wentworth-Douglass Hospital Dover New Hampshire
United States Saint Luke's Hospital of Duluth Duluth Minnesota
United States Northeast Radiation Oncology Center Dunmore Pennsylvania
United States Fairview-Southdale Hospital Edina Minnesota
United States Hardin Memorial Hospital Elizabethtown Kentucky
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States The Regional Cancer Center Erie Pennsylvania
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia
United States McLaren Cancer Institute-Flint Flint Michigan
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States University of Texas Medical Branch Galveston Texas
United States CaroMont Regional Medical Center Gastonia North Carolina
United States Gaston Hematology and Oncology Associates Gastonia North Carolina
United States UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States CHI Health Saint Francis Grand Island Nebraska
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Self Regional Healthcare Greenwood South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Greenville Health System Cancer Institute-Greer Greer South Carolina
United States Queen's Medical Center Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States Mary Bird Perkins Cancer Center - Houma Houma Louisiana
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson in Katy Houston Texas
United States The Methodist Hospital System Houston Texas
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Franciscan Health Indianapolis Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States West Michigan Cancer Center Kalamazoo Michigan
United States North Kansas City Hospital Kansas City Missouri
United States The University of Kansas Cancer Center-North Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States CHI Health Good Samaritan Kearney Nebraska
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Kettering Medical Center Kettering Ohio
United States UC San Diego Moores Cancer Center La Jolla California
United States McLaren Cancer Institute-Lapeer Region Lapeer Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States UTMB Cancer Center at Victory Lakes League City Texas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States The University of Kansas Cancer Center-Lee's Summit Lee's Summit Missouri
United States Baptist Health Lexington Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States PeaceHealth Saint John Medical Center Longview Washington
United States McKee Medical Center Loveland Colorado
United States Lowell General Hospital Lowell Massachusetts
United States Bay Area Medical Center Marinette Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Community Memorial Hospital Menomonee Falls Wisconsin
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Ascension Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Zablocki Veterans Administration Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Memorial Medical Center Modesto California
United States McLaren Cancer Institute-Macomb Mount Clemens Michigan
United States Virtua Memorial Mount Holly New Jersey
United States McLaren Cancer Institute-Central Michigan Mount Pleasant Michigan
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States MD Anderson League City Nassau Bay Texas
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Kaiser Permanente Oakland-Broadway Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States UF Cancer Center at Orlando Health Orlando Florida
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States McLaren Cancer Institute-Owosso Owosso Michigan
United States 21st Century Oncology-Palatka Palatka Florida
United States University Hospitals Parma Medical Center Parma Ohio
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Cancer Center Post Falls Idaho
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States University of Rochester Rochester New York
United States Rohnert Park Cancer Center Rohnert Park California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States South Sacramento Cancer Center Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Peninsula Regional Medical Center Salisbury Maryland
United States UCSF Medical Center-Mount Zion San Francisco California
United States North Coast Cancer Care Sandusky Ohio
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Saint Michael's Hospital Stevens Point Wisconsin
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States MD Anderson in Sugar Land Sugar Land Texas
United States Aurora Medical Center in Summit Summit Wisconsin
United States MD Anderson in The Woodlands The Woodlands Texas
United States Community Medical Center Toms River New Jersey
United States William Beaumont Hospital - Troy Troy Michigan
United States Banner University Medical Center - Tucson Tucson Arizona
United States Lewis and Faye Manderson Cancer Center Tuscaloosa Alabama
United States Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Virtua Voorhees Voorhees New Jersey
United States Aurora West Allis Medical Center West Allis Wisconsin
United States The Alyce and Elmore Kraemer Cancer Care Center West Bend Wisconsin
United States University Pointe West Chester Ohio
United States Reading Hospital West Reading Pennsylvania
United States UHHS-Westlake Medical Center Westlake Ohio
United States Diagnostic and Treatment Center Weston Wisconsin
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Aspirus UW Cancer Center Wisconsin Rapids Wisconsin
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Alive Without Progression (Progression-free Survival) Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: [1] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be > 5 mm. [2] Appearance of =1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Secondary Percentage of Participants Alive (Overall Survival) Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Secondary Percentage of Participants With Local-regional Progression Local-regional progression (LRP) is defined as progression within the planned treatment volume (PTV) or outside the PTV but within the same lobe(s) of the lung as the primary tumor or in regional lymph nodes. Progression is defined as change in a known lesion(s) meeting one of the following criteria: [1] = 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be > 5 mm. [2] Appearance of =1 new lesions. LRP time is defined as time from randomization to the date of first LRP, death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 LRP events were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Secondary Percentage of Participants With Distant Metastases Distant metastasis (DM) is defined as the appearance of = 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
Secondary Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment. From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
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