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Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-Small Cell Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Thank you

Trial Information

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-Small Cell Lung Cancer


I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on PFS in
advanced NSCLC patients who have had either stable or responding disease over the course of
their initial 4 cycles of platinum-based therapy.


I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.

II. To evaluate the additional response rate as a result of sunitinib in this setting.

III. To assess the impact of sunitinib on overall survival compared to the placebo arm.

IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of
life and symptom progression compared to placebo using the EORTC QLQ-C30 and LC13.

V. To assess VEGF haplotypes in advanced non-small cell lung cancer and sunitinib

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 vs 1), disease stage (IIIB vs IV), prior treatment with bevacizumab (yes vs no),
and gender. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) once daily on days 1-21. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO once daily on days 1-21. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.

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

Inclusion Criteria:

- Histologic or cytologic documentation of primary non-small cell lung cancer

- Stage IIIB or IV disease patients who are not candidates for combined modality
therapy (chemoradiotherapy)

- No evidence of symptomatic or untreated brain metastases, spinal cord compression, or
carcinomatous meningitis; patients with central nervous system (CNS) metastases must
be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or
>= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a
stable dose for 2 weeks prior to registration

- No cavitary lesions

- Patients must have received one chemotherapy regimen for stage IIIB or IV NSCLC; the
regimen must include four cycles of platinum-based doublet chemotherapy with or
without bevacizumab (bevacizumab may not be given beyond the fourth cycle of
chemotherapy); patients must have achieved a complete response, partial response, or
stable disease to first-line chemotherapy and have no evidence of disease
progression; patients will be registered 3-5 weeks following day 1 of cycle 4 of
prior therapy

- No prior adjuvant chemotherapy for stage I-III resected NSCLC or combined modality
therapy for stage III NSCLC

- No other primary therapy (including experimental therapy) for NSCLC; palliative
radiation therapy must have been completed at least one week before planned start of
protocol therapy

- Patients must have measurable or non-measurable disease

- Measurable disease: lesions that can be accurately measured in at least one
dimension (longest diameter to be recorded) as >= 2 cm with conventional
techniques or as >= 1 cm with spiral CT scan

- Non-measurable disease: all other lesions, including small lesions (longest
diameter < 20 mm with conventional techniques or < 10 mm with spiral computed
tomography [CT] scan) and truly non-measurable lesions; lesions that are
considered non-measurable include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Non-pregnant and non-nursing

- No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT
(QTc) interval >= 500 msec (within 2 years prior to registration); the use of agents
with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol,
probucol, haloperidol, risperidone, indapamide, flecainide) is not recommended while
on protocol therapy

- Patients with class I New York Heart Association (NYHA) heart failure are eligible;
patients with a history of class II NYHA heart failure are eligible, provided they
meet at least one of the following criteria:

- Patients with a history of class II heart failure who are asymptomatic on

- Patients with prior anthracycline exposure

- Patients who have received central thoracic radiation that included the heart in
the radiotherapy port

- Patients with a history of class III or IV NYHA heart failure within 12 months prior
to registration are not eligible

- No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft or stenting, cerebrovascular accident or transient ischemic attack within the
last year

- Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg
despite optimal medical therapy) are not eligible

- Patients who require use of therapeutic anticoagulation for thromboembolic disease
are not eligible; Note: low doses of coumadin (up to 2 mg daily) are permitted for
prophylaxis of thrombosis

- No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome

- No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis;
patients with blood-tinged or blood-streaked sputum will be permitted on study if the
hemoptysis amounts to less than 5 ml of blood per episode and less than 10 ml of
blood per 24-hour period in the best estimate of the investigator

- Patients with a history of hypothyroidism are eligible, provided they are currently

- None of the following within 28 days of beginning treatment: abdominal fistula,
gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound,
ulcer, or bone fracture

- The following inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited within 7 days
before beginning and during treatment with sunitinib: azole antifungals
(ketoconazole, itraconozole), diltiazem, clarithromycin, erythromycin, verapamil,
delavirdine, and HIV protease inhibitors (indinavir, saquinavir, ritonavir,
atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12
days before beginning and during treatment with sunitinib: rifampin, rifabutin,
carbamazepine, phenobarbital, phenytoin, St. John's Wort, efavirenz, tipranavir;
other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is

- Patients unable to take oral medication are not eligible

- Granulocytes >= 1,500/mcl

- Platelet count >= 100,000/mcl

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

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=< 2.5 x ULN;
patients with liver metastases may have AST and ALT =< 5 x ULN; all other patients
will have AST and ALT =< 2.5 x ULN

- Creatinine =< 1.5 mg/dl

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

PFS will be characterized by the Kaplan-Meier method. PFS will be performed using the intent-to-treat principle, which included all randomized patients. The comparisons of treatment arms on PFS will be done using the stratified log ranked.

Outcome Time Frame:

Time from the date of randomization of non-progressing patients following the first-line therapy to the date of disease progression or death of any cause, whichever comes first, assessed up to 5 years

Safety Issue:


Principal Investigator

Mark Socinski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin  54868
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
Jupiter Medical Center Jupiter, Florida  33458
Elkhart Clinic Elkhart, Indiana  46515
Mount Sinai Medical Center CCOP Miami Beach, Florida  33140
Michiana Hematology Oncology PC-Elkhart Elkhart, Indiana  46514
Michiana Hematology Oncology PC-Plymouth Plymouth, Indiana  46563
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Michiana Hematology Oncology-PC Westville Westville, Indiana  46391
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Saint Mary's Regional Medical Center Lewiston, Maine  04240
Michiana Hematology Oncology PC-Niles Niles, Michigan  49120
University of Missouri - Ellis Fischel Columbia, Missouri  65203
Veterans Administration Columbia, Missouri  65201
Syracuse Veterans Administration Medical Center Syracuse, New York  13210
East Carolina University Greenville, North Carolina  27858
Duke Raleigh Hospital Raleigh, North Carolina  27609
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
Roper Hospital Charleston, South Carolina  29401
Cancer Centers of the Carolinas - Faris Greenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Radiation Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas-Greer Medical Oncology Greer, South Carolina  29650
Nashville Oncology Associates PC Nashville, Tennessee  37203
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Wheaton Franciscan Cancer Care - All Saints Racine, Wisconsin  53405
Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Riverview Hospital Wisconsin Rapids, Wisconsin  54494
Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach, California  90806
Kaiser Permanente Los Angeles Medical Center Los Angeles, California  90027
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma  
Kaiser Anaheim Medical Center Anaheim, California  92807
Kaiser Permanente Medical Group - Baldwin Park Baldwin Park, California  91706
Kaiser Foundation Hospital Bellflower, California  90706
Kaiser Permanente Hospital Fontana, California  92335
Kaiser Permanente - Harbor City Harbor City, California  90710
Kaiser Permanente-West Los Angeles Los Angeles, California  90034
Epic Care-Oakland Oakland, California  94612
Kaiser Permanente - Panorama City Panorama City, California  91402
Palchak David MD Pismo Beach, California  93449
Kaiser Permanente at San Diego San Diego, California  92120
Kaiser Permanente Health Care San Marcos, California  92069
Spector, David MD (UIA Investigator) Moline, Illinois  61265
Saint Luke's South Hospital Overland Park, Kansas  66213
Kansas City CCOP Prairie Village, Kansas  66208
Doctors Carrol, Sheth, Raghavan Louisville, Kentucky  40215
Hematology and Oncology Clinic Baton Rouge, Louisiana  70809
Veterans Administration Medical Center Baltimore, Maryland  21201
Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City, Missouri  65109
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Joseph Oncology Inc Saint Joseph, Missouri  64507
Comprehensive Cancer Care PC Saint Louis, Missouri  63141
Arnot Ogden Medical Center Elmira, New York  14905
Durham Veterans Affairs Medical Center Durham, North Carolina  27705
Mount Carmel East Hospital Columbus, Ohio  43213
The Mark H Zangmeister Center Columbus, Ohio  43219
Southern Ohio Medical Center Portsmouth, Ohio  45662
Cancer Care Associates-Mercy Oklahoma City, Oklahoma  73120
Dallas VA Medical Center Dallas, Texas  75216
Memorial Hospital Of Martinsville Martinsville, Virginia  24115
Saint Mary's Medical Center Huntington, West Virginia  25702
Gundersen Lutheran La Crosse, Wisconsin  54601
Saint Nicholas Hospital Madison, Wisconsin  53715
Columbia Saint Mary's Water Tower Medical Commons Milwaukee, Wisconsin  53211
Alegent Health Lakeside Hospital Omaha, Nebraska  68130
Beaufort Memorial Hospital Beaufort, South Carolina  29902
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Walter Reed National Military Medical Center Bethesda, Maryland  20889
Kaiser Permanente-Mission San Diego, California  92108
Hunter Holmes McGuire Veterans Administration Medical Center Richmond, Virginia  23249
Gulfport Memorial Hospital Gulfport, Mississippi  39502
VA Medical Center - University of Iowa Iowa City, Iowa  52246
Carle Foundation - Carle Cancer Center Urbana, Illinois  61801
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PC East Syracuse, New York  13057
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Essentia Health Saint Mary's Medical Center Duluth, Minnesota  55805
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota  58103
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Springfield Regional Medical Center Springfield, Ohio  45505
Edward Hospital/Cancer Center Naperville, Illinois  60540
Saint Louis Cancer and Breast Institute-South City Saint Louis, Missouri  63109
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
Self Regional Healthcare Greenwood, South Carolina  29646
PeaceHealth Southwest Medical Center Vancouver, Washington  98664
Aurora Cancer Care-Southern Lakes Elkhorn, Wisconsin  53121
Cancer Care Associates-Norman Norman, Oklahoma  73071
Mercy Physicians of Oklahoma-Lakeside Oklahoma City, Oklahoma  73120
Providence Willamette Falls Medical Center Oregon City, Oregon  97045
Cancer Center of Western Wisconsin New Richmond, Wisconsin  54017
Feather River Cancer Center Paradise, California  95969
Nash General Hospital Rocky Mount, North Carolina  27804
Trinity's Tony Teramana Cancer Center Steubenville, Ohio  43952
Associated Medical Specialists PA dba Coastal Cancer Center Myrtle Beach, South Carolina  29572