New drug combo tested for tough lung cancer – modest hopes

NCT ID NCT00453154

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at adding sunitinib malate (a drug that blocks tumor blood flow) to standard chemotherapy for people with extensive-stage small cell lung cancer. The trial involved 156 participants and aimed to find the best dose and see if maintenance sunitinib after chemo could delay cancer growth. Results showed no major improvement in progression-free survival compared to chemo alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: sunitinib malate (Sutent)
What this could lead to: If successful, this could point toward a new maintenance treatment to delay cancer progression in extensive-stage small cell lung cancer.
What could go wrong: This is an early-phase trial with a small number of participants. The drug may not improve survival and can cause side effects like fatigue, low blood counts, and thyroid problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

156 people

The number who actually took part.

Started

Mar 2007

Finished

Aug 2015

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All patients must have histologically or cytologically documented small cell lung cancer * Eligible disease stages: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastatic, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy * All patients must have measurable disease: * Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan * Lesions that are considered non-measurable, which would make the patient not eligible, 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 * No prior chemotherapy for small cell lung cancer (SCLC) * Radiation therapy must have been completed at least one week before initiation of protocol therapy * Common Toxicity Criteria (CTC) performance status: * Phase IB: 0-1 * Phase II: 0-2 * No "currently active" second malignancy other than non-melanoma skin cancers * No history of brain metastases, spinal cord compression, or carcinomatous meningitis * No ongoing cardiac dysrhythmias, atrial fibrillation, or QTc interval \>= 500 msec; the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, pedridel, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy * Patients with class I New York Heart Association (NYHA) are eligible; patients with a history of class II NYHA are eligible, provided they meet the following criteria: * Patients with a history of class II heart failure who are asymptomatic on treatment * 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 * Additionally, no myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident including transient ischemic attack, or pulmonary embolism 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 doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT) international normalized ratio (INR) is =\< 1.5 * No evidence of hemoptysis within 4 weeks prior to starting study treatment; 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 * None of the following within 28 days of treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture * The use of the following specific inhibitors and inducers of cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not permitted; the following inhibitors of CYP3A4 are prohibited within 7 days before and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus (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 there use is discouraged * Non-pregnant and non-nursing * Granulocytes \>= 1,500/ul * Platelets \>= 100,000/ul * Creatinine clearance \>= 70 ml/min * Total bilirubin =\< 1.5 mg/dl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) (patients w/ liver metastases may have AST/ALT =\< 5 x ULN) * Partial thromboplastin time (PTT) =\< 1.5 x ULN

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Extensive stage lung small cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extensive stage lung small cell carcinoma Recurrent lung small cell carcinoma

Contacts and locations

Locations

AMITA Health Adventist Medical Center

La Grange, Illinois, 60525, United States
Addison Gilbert Hospital

Gloucester, Massachusetts, 01930, United States
Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States
Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122, United States
Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States
Arroyo Grande Community

Arroyo Grande, California, 93420, United States
Bay Area Breast Surgeons Inc

Emeryville, California, 94608, United States
Bay Area Tumor Institute

Oakland, California, 94609, United States
Beaufort Memorial Hospital

Beaufort, South Carolina, 29902, United States
Beebe Medical Center

Lewes, Delaware, 19958, United States
Bromenn Regional Medical Center

Normal, Illinois, 61761, United States
CHI Health Saint Francis

Grand Island, Nebraska, 68803, United States
Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States
Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States
Community Cancer Center Foundation

Normal, Illinois, 61761, United States
Community Howard Regional Health

Kokomo, Indiana, 46904, United States
Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States
Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States
Creighton University Medical Center

Omaha, Nebraska, 68131, United States
Danville Regional Medical Center

Danville, Virginia, 24541, United States
Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, 94806, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States
Eastern Maine Medical Center

Bangor, Maine, 04401, United States
El Camino Hospital

Mountain View, California, 94040, United States
Elkhart Clinic

Elkhart, Indiana, 46514-2098, United States
Elkhart General Hospital

Elkhart, Indiana, 46515, United States
Eureka Hospital

Eureka, Illinois, 61530, United States
FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States
Florida Cancer Specialists-Gainesville Cancer Center

Gainesville, Florida, 32605, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, 46845, United States
Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States
Glens Falls Hospital

Glens Falls, New York, 12801, United States
Graham Hospital Association

Canton, Illinois, 61520, United States
Great Plains Health Callahan Cancer Center

North Platte, Nebraska, 69101, United States
Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States
Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, 13057, United States
Hematology and Oncology Associates-Oakland

Oakland, California, 94609, United States
Highland General Hospital

Oakland, California, 94602, United States
Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States
Holy Family Medical Center

Monmouth, Illinois, 61462, United States
Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States
IU Health La Porte Hospital

La Porte, Indiana, 46350, United States
Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton

Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States
Illinois CancerCare-Community Cancer Center

Normal, Illinois, 61761, United States
Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana

Havana, Illinois, 62644, United States
Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States
Illinois CancerCare-Monmouth

Monmouth, Illinois, 61462, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru

Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States
Illinois CancerCare-Spring Valley

Spring Valley, Illinois, 61362, United States
Illinois Valley Hospital

Peru, Illinois, 61354, United States
Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States
Jupiter Medical Center

Jupiter, Florida, 33458, United States
Kewanee Hospital

Kewanee, Illinois, 61443, United States
LRGHealthcare-Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States
Lakeland Hospital Niles

Niles, Michigan, 49120, United States
Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, 49085, United States
Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States
Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States
Mason District Hospital

Havana, Illinois, 62644, United States
McLeod Regional Medical Center

Florence, South Carolina, 29506, United States
Mcdonough District Hospital

Macomb, Illinois, 61455, United States
MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Memorial Health University Medical Center

Savannah, Georgia, 31404, United States
Memorial Hospital

Carthage, Illinois, 62321, United States
Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States
Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, 46514, United States
Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, 46563, United States
Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-Westville

Westville, Indiana, 46391, United States
Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States
Miriam Hospital

Providence, Rhode Island, 02906, United States
Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States
Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States
Nebraska Cancer Research Center

Lincoln, Nebraska, 68510, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301, United States
New Hampshire Oncology Hematology PA-Hooksett

Hooksett, New Hampshire, 03106, United States
Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46628, United States
OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, 61350, United States
PCR Oncology

Arroyo Grande, California, 93420, United States
Pekin Hospital

Pekin, Illinois, 61554, United States
Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States
Perry Memorial Hospital

Princeton, Illinois, 61356, United States
Proctor Hospital

Peoria, Illinois, 61614, United States
Ralph Lauren Center for Cancer Care and Prevention

New York, New York, 10035, United States
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States
Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, 46545, United States
Saint Margaret's Hospital

Spring Valley, Illinois, 61362, United States
South Bend Clinic

South Bend, Indiana, 46617, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Tom K Lee Inc

Oakland, California, 94609, United States
UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States
Union Hospital of Cecil County

Elkton, Maryland, 21921, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Fremont

Fremont, California, 94538, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.