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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00986674
Other study ID # NCI-2011-01976
Secondary ID E4508U10CA021115
Status Completed
Phase Phase 2
First received September 29, 2009
Last updated September 19, 2014
Start date September 2009
Est. completion date December 2013

Study information

Verified date March 2014
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV 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 or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.


Description:

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival of patients with non-small cell lung cancer (NSCLC) randomized to carboplatin plus paclitaxel plus cetuximab or carboplatin plus paclitaxel plus cixutumumab (IMC-A12) or carboplatin plus paclitaxel plus cetuximab plus cixutumumab.

SECONDARY OBJECTIVES:

I. To evaluate the response rate, disease control rate (complete response plus partial response plus stable disease), and toxicities for each arm.

II. To evaluate epidermal growth factor receptor (EGFR) by Immunohistochemistry (IHC), mutation, and gene copy number, Insulin-like growth factor 1 receptor (IGF-1R) and Insulin-like growth factor 2 receptor (IGF-2R) expression (both phosphorylated and unphosphorylated states), expression of p-AKT (ie, Protein Kinase B) by IHC, and k-ras mutation.

III. Plasma-based biomarkers will be evaluated for total and free insulin-like growth factor 1 and 2, IGF-growth factor binding protein 3 (IGFBP3) and circulating levels of epidermal growth factor (EGF) and Transforming growth factor (TGF) alpha.

IV. To evaluate overall survival on each of the three arms.

OUTLINE: This is a multicenter study. Patients are stratified according to gender and histology (squamous cell vs non-squamous cell). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive carboplatin intravenously (IV) over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.

Tumor tissue samples are collected at baseline for analysis of EGFR expression by IHC, mutation, and gene copy number; IGF-1R and IGF-2R expression (both phosphorylated and unphosphorylated states); p-AKT expression by IHC; and k-ras mutation. Blood, serum, and plasma samples are collected periodically for biomarker analysis.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: 200 patients


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage IIIB disease

- T4, NX with nodule in ipsilateral lung lobe allowed provided patient is not a candidate for combined chemotherapy and radiotherapy

- Stage IV disease (includes M1a and M1b)

- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

- Ineligible for or refused treatment with bevacizumab

- No untreated or symptomatic central nervous system (CNS) metastases

- Patients with a history of CNS metastases that are definitively treated, stable, and controlled are eligible provided the following criteria are met:

- Definitive therapy (surgery and/or radiotherapy) has been administered

- Not planning to undergo additional treatment for brain metastases

- Clinically stable

- Off corticosteroids or on a stable dose of corticosteroids for = 14 days before study entry

- ECOG performance status 0-1

- Leukocytes > 3,000/mm^3

- Absolute neutrophil count (ANC) > 1,500/mm^3

- Hemoglobin > 9 g/dL

- Platelet count > 100,000/mm^3

- Total bilirubin = 1.5 times upper limit of normal (ULN)

- Aspartate Aminotransferase (AST) < 3 times ULN (< 5 times ULN if elevations due to liver metastases)

- Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min

- Fasting serum glucose < 120 mg/dL

- Partial thromboplastin time (PTT) = 1.2 times ULN and international normalized ratio (INR) = 1.5 (unless patient is on anticoagulation therapy)

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after the last dose of cixutumumab

- No poorly controlled diabetes mellitus

- Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range and they are on a stable dietary or therapeutic regimen for this condition

- No other prior or concurrent malignancy, except for the following:

- Curatively treated malignancy with no known active disease for = 3 years AND is considered to be at low risk for recurrence by the treating physician

- Adequately treated nonmelanoma skin cancer or lentigo maligna with no evidence of disease

- Adequately treated cervical carcinoma in situ with no evidence of disease

- Prostatic intraepithelial neoplasia with no evidence of prostate cancer

- Concurrent therapeutic anticoagulation allowed provided there is no bleeding and patient is on a stable dose of anticoagulation therapy (e.g., Warfarin with an INR of 2-3) for > 2 weeks prior to study entry

- At least 21 days since prior radiotherapy

- More than 4 weeks since prior major surgery or hormonal therapy (other than hormone replacement therapy) and recovered

- More than 1 year since prior neoadjuvant or adjuvant chemotherapy

Exclusion criteria:

- Small cell lung cancer or mixed small cell and NSCLC

- History of allergic reactions attributed to compounds of similar chemical or biological composition to cixutumumab

- History of any medical or psychiatric condition, addictive disorder, or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results

- Prior agents targeting the EGFR or Insulin-like growth factor (IGFR) pathways

- Prior therapy for advanced NSCLC, except for surgery and/or radiotherapy

- Prior systemic therapy, including bevacizumab for advanced stage NSCLC

- Pregnant or nursing

- Peripheral neuropathy > grade 1 as per Common Terminology Criteria for Adverse Event (CTCAE) v 4.0

- History of or suspected interstitial pneumonitis or pulmonary fibrosis on imaging

- Significant uncontrolled cardiac disease within the past 6 months, including any of the following:

- Uncontrolled hypertension (BP > 150/100 mm Hg)

- Unstable angina

- Recent myocardial infarction

- Uncontrolled congestive heart failure

- Cardiomyopathy with decreased ejection fraction

- Arterial thrombosis, pulmonary embolus, deep vein thrombosis, or hemorrhagic disorders within the past 28 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
cixutumumab
Given IV
Drug:
carboplatin
Given IV
paclitaxel
Given IV
Biological:
cetuximab
Given IV

Locations

Country Name City State
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States New York Oncology Hematology PC - Albany Albany New York
United States New York Oncology Hematology PC -Albany Medical Center Albany New York
United States New York Oncology Hematology PC - Amsterdam Amsterdam New York
United States Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Fox Valley Hematology and Oncology Appleton Wisconsin
United States The Medical Center of Aurora Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Mary Rutan Hospital Bellefontaine Ohio
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Boulder Community Hospital Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Fairview Ridges Hospital Burnsville Minnesota
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Cedar Rapids Oncology Association Cedar Rapids Iowa
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States West Virginia University Charleston Charleston West Virginia
United States University of Virginia Charlottesville Virginia
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Case Western Reserve University Cleveland Ohio
United States North Coast Cancer Care-Clyde Clyde Ohio
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Columbus CCOP Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Danbury Hospital Danbury Connecticut
United States Geisinger Medical Center Danville Pennsylvania
United States Oakwood Hospital Dearborn Michigan
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Cancer Research Program CCOP Denver Colorado
United States Exempla Saint Joseph Hospital Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States Saint John Hospital and Medical Center Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Essentia Health Duluth Clinic CCOP Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Evanston CCOP-NorthShore University HealthSystem Evanston Illinois
United States Hunterdon Medical Center Flemington New Jersey
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Vanderbilt-Ingram Cancer Center Cool Springs Franklin Tennessee
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Green Bay Wisconsin
United States Saint Francis Hospital and Medical Center Hartford Connecticut
United States Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Geisinger Medical Center-Cancer Center Hazelton Hazleton Pennsylvania
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States New York Oncology Hematology PC-Hudson Hudson New York
United States Cancer Center of Kansas-Independence Independence Kansas
United States Indiana University Medical Center Indianapolis Indiana
United States Richard L. Roudebush Veterans Affairs Medical Center Indianapolis Indiana
United States Wishard Hospital Indianapolis Indiana
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran La Crosse Wisconsin
United States Indiana University Health La Porte Hospital La Porte Indiana
United States IU Health Arnett Lafayette Indiana
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States Sparrow Hospital Lansing Michigan
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States New York Oncology Hematology PC - Latham Latham New York
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Saint Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Medical Center of Central Georgia Macon Georgia
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States UW Health Oncology - 1 South Park Madison Wisconsin
United States Manchester Memorial Hospital Manchester Connecticut
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Bay Area Medical Center Marinette Wisconsin
United States Marshfield Clinic Marshfield Wisconsin
United States Saint Luke's Hospital Maumee Ohio
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Sharis, Christine M MD (UIA Investigator) Moline Illinois
United States Spector, David MD (UIA Investigator) Moline Illinois
United States Stoffel, Thomas J MD (UIA Investigator) Moline Illinois
United States Trinity Medical Center Moline Illinois
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital Monroe Michigan
United States Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey
United States Knox Community Hospital Mount Vernon Ohio
United States Nashville Oncology Associates PC Nashville Tennessee
United States Licking Memorial Hospital Newark Ohio
United States Newark Beth Israel Medical Center Newark New Jersey
United States Cancer Center of Kansas - Newton Newton Kansas
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Fisher-Titus Medical Center Norwalk Ohio
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium CCOP Omaha Nebraska
United States UHHS-Chagrin Highlands Medical Center Orange Village Ohio
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois Oncology Research Association CCOP Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania
United States Albert Einstein Medical Center Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Saint Joseph Mercy Port Huron Port Huron Michigan
United States Pottstown Memorial Medical Center Pottstown Pennsylvania
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States New York Oncology Hematology PC - Rexford Rexford New York
United States Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Saint Mary's of Michigan Saginaw Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Metro-Minnesota CCOP Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States North Coast Cancer Care Sandusky Ohio
United States Mercy Hospital Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Hematology Oncology Associates Sioux City Iowa
United States Memorial Hospital of South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Saint Margaret's Hospital Spring Valley Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Lakeland Hospital St. Joseph Michigan
United States Stanford University Hospitals and Clinics Stanford California
United States Geisinger Medical Group State College Pennsylvania
United States Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Flower Hospital Sylvania Ohio
United States Scott and White Memorial Hospital Temple Texas
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States New York Oncology Hematology PC - Troy Troy New York
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Saint Ann's Hospital Westerville Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Wheeling Hospital Wheeling West Virginia
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Main Office Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wichita CCOP Wichita Kansas
United States Geisinger Wyoming Valley Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Riverview Hospital Wisconsin Rapids Wisconsin
United States Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota
United States Lankenau Hospital Wynnewood Pennsylvania
United States Mainline Health CCOP Wynnewood Pennsylvania
United States Genesis HealthCare System Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .
All eligible and treated patients were included in the analysis.
Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3 No
Secondary Overall Survival Overall survival is defined as time from registration to death from any cause. assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3 No
Secondary Response Rate Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR. Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3 No
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