Lung Cancer Clinical Trial

Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer

Summary

Maintenance treatment of advanced stage squamous cell NSCLC.

Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell NSCLC.

Subjects who discontinued treatment from the maintenance part for any reason other than withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that had a visit 28 days after progression or discontinuation.

Those who entered Follow-up without progression continued with follow-up scans according to standard of care (SOC) until documentation of progression of disease. Additionally, subjects were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up to approximately 5 years after the last subject was randomized.

View Full Description

Full Description

The sponsor used 15 Sep 2017 as the database cut-off date.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years of age at the time of signing the Informed Consent Form.
Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.

Able to adhere to the study visit schedule and other protocol requirements

Disease Specific

Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.
No other current active malignancy requiring anticancer therapy.
Radiographically documented measurable disease at study entry (as defined by the Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria).
No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
Absolute neutrophil count ≥ 1500 cells/mm^3.
Platelets ≥ 100,000 cells/mm^3.
Hemoglobin ≥ 9 g/dL.
Aspartate transaminase/serum glutamic oxaloacetic transaminase, alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
Creatinine ≤ 1.5 mg/dL.
Expected survival of > 12 weeks for the Induction part of the study.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction

Pregnancy

Females of childbearing potential [defined as a sexually mature woman who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:

agree to take a pregnancy test prior to starting study medication and throughout the study participation.
commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations.

Male subjects must:

c. agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy.

Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment into the Induction and Maintenance parts of the study (except if specified at study entry only):

Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to first dose of study drug).
Only evidence of disease is non-measurable at study entry.
Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
Venous thromboembolism within 6 months prior to signing Informed Consent Form.
Current congestive heart failure (New York Heart Association class II-IV).
History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
Treatment with any investigational product within 28 days prior to signing Informed Consent Form.
History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.
Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.
Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
Subject has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) - all treatments that should have been completed 6 months prior to signing informed consent form (ICF).
Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product (IP), and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
Pregnant and nursing females.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

427

Study ID:

NCT02027428

Recruitment Status:

Completed

Sponsor:

Celgene

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 115 Locations for this study

See Locations Near You

Clearview Cancer Institute Oncology Specialties, P.C
Huntsville Alabama, 35805, United States
Palo Verde Hematology Oncology, Ltd.
Glendale Arizona, 85304, United States
Arizona Clinical Research Center
Tucson Arizona, 85715, United States
Genesis Cancer Center
Hot Springs Arkansas, 71913, United States
City of Hope Cancer Center
Duarte California, 91010, United States
Cancer Care Associates of Fresno Medical Group Inc
Fresno California, 93720, United States
University of California San Diego Moores Cancer Center
La Jolla California, 92093, United States
Clinical Trials and Research Associates
Montebello California, 90640, United States
VA Palo Alto Health Care System
Palo Alto California, 94304, United States
Rocky Mountain Cancer Centers, LLP
Denver Colorado, 80218, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Lynn Cancer Institute
Boca Raton Florida, 33486, United States
Florida Cancer Specialists
Fort Myers Florida, 33916, United States
Watson Clinic, LLP Center for Cancer Care and Research
Lakeland Florida, 33805, United States
University of Miami Miller School of Medicine Jackson Memorial Hospital
Miami Florida, 33136, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Orlando Health, Inc
Orlando Florida, 32806, United States
Memorial Cancer Institute West
Pembroke Pines Florida, 33028, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
University Cancer and Blood Center, LLC
Athens Georgia, 30607, United States
University of Chicago
Chicago Illinois, 60637, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet Illinois, 60435, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Indiana University Medical Center
Indianapolis Indiana, 46202, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis Indiana, 46260, United States
Kansas University Medical Center
Westwood Kansas, 66205, United States
Cancer Center of Kansas (MAT)
Wichita Kansas, 67208, United States
Kentucky Cancer Clinic
Hazard Kentucky, 41701, United States
Norton Healthcare
Louisville Kentucky, 40202, United States
University of Louisville, J.G. Brown Cancer Center
Louisville Kentucky, 40202, United States
Norton Cancer Institute Louisville Oncology
Louisville Kentucky, 40207, United States
LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Maine Research Associates
Auburn Maine, 04210, United States
Eastern Maine Medical Center
Brewer Maine, 04412, United States
Center For Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Meritus Medical Center
Hagerstown Maryland, 21742, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Detroit Clinical Research Center
Farmington Hills Michigan, 48334, United States
Western Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
St Joseph Oncology
Saint Joseph Missouri, 64507, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Medical Research Institute
Springfield Missouri, 65804, United States
Englewood Hospital and Medical Center
Englewood New Jersey, 07631, United States
Hematology-Oncology Associates of NNJ, P
Morristown New Jersey, 07960, United States
New York Oncology Hematology P.C.
Albany New York, 12206, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Montefiore Medical Center Albert Einstein Cancer Center
Bronx New York, 10467, United States
Clinical Research Alliance
Lake Success New York, 11042, United States
NYU Langone Medical Center
Lake Success New York, 11042, United States
Beth Israel Medical Centers
New York New York, 10003, United States
NYU Langone Medical Center
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai Medical Center
New York New York, 10029, United States
Rochester General Hospital
Rochester New York, 14621, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Carolinas Medical Center
Charlotte North Carolina, 28204, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Moses H. Cone Regional Cancer Center
Greensboro North Carolina, 27403, United States
Hematology and Oncology Associates, Inc.
Canton Ohio, 44708, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45242, United States
University Hospitals Case Medical Center
Cleveland Ohio, 44106, United States
The Mark H. Zangmeister Center
Columbus Ohio, 43219, United States
Tri-County Hematology and Oncology Associates
Massillon Ohio, 44646, United States
Toledo Community Oncology Program
Toledo Ohio, 43623, United States
Mercy Clinic Oklahoma Communities, Inc.
Oklahoma City Oklahoma, 73102, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Erie Regional Cancer Center
Erie Pennsylvania, 16505, United States
Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania Health Systems
Philadelphia Pennsylvania, 19104, United States
Allegheny Singer Research Institute
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Medical Center - Cancer Pavilion
Pittsburgh Pennsylvania, 15232, United States
Greenville Hospital System
Greenville South Carolina, 29605, United States
Chattanooga Oncology Hematology Care
Chattanooga Tennessee, 37404, United States
Associates in Oncology and Hematology
Chattanooga Tennessee, 37421, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
TX Onc, PA- Beaumont
Beaumont Texas, 77702, United States
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston Texas, 78235, United States
Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
UT Health Oncology
Houston Texas, 77030, United States
Millenium Oncology
Houston Texas, 77090, United States
TX Onc Tyler Cancer Center
Tyler Texas, 75702, United States
Columbia Basin Hematology and Oncology
Kennewick Washington, 99336, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
St Mary's Medical Center
Huntington West Virginia, 25702, United States
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
Martinsburg West Virginia, 25401, United States
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
Morgantown West Virginia, 26506, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
St. Antonius Hospital
Eschweiler , 52249, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting , 82131, Germany
Diakoniekrankenhaus Halle
Halle (Saale) , 6114, Germany
Universitatsklinikum Halle Saale
Halle , 06120, Germany
Thorax Klinik
Heidelberg , 69126, Germany
Universitat Des Saarlandes
Homburg , 66421, Germany
Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim
Koln , 51109, Germany
Klinik Loewenstein gGmbH
Loewenstein , 74245, Germany
Lungenklinik Lostau gGmbH
Lostau , 39291, Germany
Universitatsklinikum Ulm
Ulm , 89081, Germany
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino , 83100, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona , 23100, Italy
Istituto Nazionale Per La Ricerca Sul Cancro
Genova , 16132, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Azienda Ospedaliera San Gerardo
Monza , 20900, Italy
Istituto Nazionale Tumori Regina Elena di Roma
Roma , 00144, Italy
Ospedale San Vincenzo Taormina
Taormina , 98039, Italy
Intituto Catalán de Oncología de Girona
Girona , 17007, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid , 28222, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Hospital Universitario Lozano Blesa
Zaragoza , 50009, Spain
Churchhill Hospital
Oxford , OX3 7, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

427

Study ID:

NCT02027428

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider