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Extensive Stage Lung Small Cell CarcinomaPhase 1/2NCT00453154

Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer

A Phase 1/2 study testing Carboplatin, Cisplatin and Etoposide in people with Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, run by National Cancer Institute (NCI) at 125 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Cisplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
125 sitesUnited States
Study dates
15 Mar 2007to 20 Aug 2015
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 39Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

125 sites in 1 country.

125 sites in 1 country

United States125 sites

  • Arroyo Grande Community

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Florida Cancer Specialists-Gainesville Cancer Center

    Gainesville, Florida, 32605

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • AMITA Health Adventist Medical Center

    La Grange, Illinois, 60525

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • LRGHealthcare-Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • El Camino Hospital

    Mountain View, California, 94040

  • Ralph Lauren Center for Cancer Care and Prevention

    New York, New York, 10035

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Lakeland Hospital Niles

    Niles, Michigan, 49120

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Illinois CancerCare-Community Cancer Center

    Normal, Illinois, 61761

  • Great Plains Health Callahan Cancer Center

    North Platte, Nebraska, 69101

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Illinois CancerCare-Spring Valley

    Spring Valley, Illinois, 61362

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study

This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the phase II dose for sunitinib (sunitinib malate) combined with cisplatin and etoposide. (Phase IB) II. To compare the progression-free survival of patients with extensive stage small cell lung cancer treated with cisplatin or carboplatin and etoposide followed by maintenance sunitinib to patients receiving the same chemotherapy followed by placebo. (Phase II)

SECONDARY OBJECTIVES:

  1. To assess the single agent response rate for sunitinib given as monotherapy after chemotherapy. (Phase II) II. To assess the overall survival of patients treated with cisplatin or carboplatin and etoposide followed by sunitinib. (Phase II) III. To evaluate the toxicity and tolerability of maintenance sunitinib after cisplatin or carboplatin and etoposide. (Phase II) IV. To determine the association between vascular endothelial growth factor (VEGF) plasma levels and tumor response. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a randomized phase II study.

PHASE I (close to accrual 5/17/08):

COMBINATION THERAPY: Patients receive cisplatin or carboplatin intravenously (IV) on day 1, etoposide IV on days 1-3, and sunitinib malate orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive sunitinib malate PO alone QD. Treatment continues in the absence of disease progression or unacceptable toxicity.

PHASE II:

COMBINATION THERAPY: Patients receive cisplatin or carboplatin and etoposide as in Phase I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 3-8 weeks after completion of combination chemotherapy or >= 4 courses of combination therapy, patients with a responding or stable disease are randomized to 1 of 2 treatment arms. All patients must be euthyroid before starting on maintenance therapy.

ARM I: Patients receive sunitinib malate PO QD. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm I.

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

Being tested
Carboplatin, Cisplatin, Etoposide, Laboratory Biomarker Analysis, Placebo Administration
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Placebo AdministrationOther

    Given PO

  • Sunitinib MalateDrug

    Also called SU011248, SU11248, sunitinib, Sutent

    Given PO

Study groups in NCT00453154
Study groupRoleWhat they receive
Arm I (Combination Chemotherapy + Sunitinib Maintenance)ExperimentalParticipants will receive the following combination chemotherapy for 4-6 cycles (21 days): Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Other: Laboratory Biomarker Analysis; Drug: Sunitinib Malate
Arm II (Combination Chemotherapy + Placebo Maintenance)Active comparatorParticipants will receive the following combination chemotherapy for 4-6 cycles (21 days): Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Other: Laboratory Biomarker Analysis; Other: Placebo Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)

    The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy).

    Measured: 21 days

  2. Progression-free Survival (Phase II)

    Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Overall Survival

    Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.

    Measured: Up to 3 years

  2. Number of Participants With Overall Tumor Response

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2007 (estimated)
  2. Study start15 Mar 2007
  3. Primary completion30 Jun 2013
  4. Study completion20 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00453154
Sponsor's protocol ID
NCI-2009-00465
Other IDs
NCI-2009-00465, CDR0000538229, CALGB 30504, CALGB-30504, U10CA180821, U10CA031946
Status last verified
May 2026
First submitted
27 Mar 2007
Last updated
16 Jun 2026

Publications

  • Marzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909.

    PubMed 39113428

  • Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.

    PubMed 36184621

  • Ready NE, Pang HH, Gu L, Otterson GA, Thomas SP, Miller AA, Baggstrom M, Masters GA, Graziano SL, Crawford J, Bogart J, Vokes EE. Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study-CALGB 30504 (Alliance). J Clin Oncol. 2015 May 20;33(15):1660-5. doi: 10.1200/JCO.2014.57.3105. Epub 2015 Mar 2.

    PubMed 25732163

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Carboplatin, Cisplatin and Etoposide in people with Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, run by National Cancer Institute (NCI) at 125 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00453154, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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