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.
Full Description
The sponsor used 15 Sep 2017 as the database cut-off date.
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.
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There are 115 Locations for this study
Huntsville Alabama, 35805, United States
Glendale Arizona, 85304, United States
Tucson Arizona, 85715, United States
Hot Springs Arkansas, 71913, United States
Duarte California, 91010, United States
Fresno California, 93720, United States
La Jolla California, 92093, United States
Montebello California, 90640, United States
Palo Alto California, 94304, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06510, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33916, United States
Lakeland Florida, 33805, United States
Miami Florida, 33136, United States
Ocala Florida, 34474, United States
Orlando Florida, 32806, United States
Pembroke Pines Florida, 33028, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Chicago Illinois, 60637, United States
Joliet Illinois, 60435, United States
Niles Illinois, 60714, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67208, United States
Hazard Kentucky, 41701, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70112, United States
Auburn Maine, 04210, United States
Brewer Maine, 04412, United States
Bethesda Maryland, 20817, United States
Hagerstown Maryland, 21742, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Farmington Hills Michigan, 48334, United States
Kalamazoo Michigan, 49007, United States
Saint Joseph Missouri, 64507, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Englewood New Jersey, 07631, United States
Morristown New Jersey, 07960, United States
Albany New York, 12206, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Lake Success New York, 11042, United States
Lake Success New York, 11042, United States
New York New York, 10003, United States
New York New York, 10016, United States
New York New York, 10029, United States
Rochester New York, 14621, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28204, United States
Goldsboro North Carolina, 27534, United States
Greensboro North Carolina, 27403, United States
Canton Ohio, 44708, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43219, United States
Massillon Ohio, 44646, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73102, United States
Oklahoma City Oklahoma, 73104, United States
Erie Pennsylvania, 16505, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37404, United States
Chattanooga Tennessee, 37421, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Beaumont Texas, 77702, United States
Fort Sam Houston Texas, 78235, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Tyler Texas, 75702, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98104, United States
Huntington West Virginia, 25702, United States
Martinsburg West Virginia, 25401, United States
Morgantown West Virginia, 26506, United States
Milwaukee Wisconsin, 53226, United States
Eschweiler , 52249, Germany
Gauting , 82131, Germany
Halle (Saale) , 6114, Germany
Halle , 06120, Germany
Heidelberg , 69126, Germany
Homburg , 66421, Germany
Koln , 51109, Germany
Loewenstein , 74245, Germany
Lostau , 39291, Germany
Ulm , 89081, Germany
Avellino , 83100, Italy
Bologna , 40138, Italy
Cremona , 23100, Italy
Genova , 16132, Italy
Milano , 20141, Italy
Monza , 20900, Italy
Roma , 00144, Italy
Taormina , 98039, Italy
Girona , 17007, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Majadahonda, Madrid , 28222, Spain
Oviedo , 33011, Spain
Valencia , 46014, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Oxford , OX3 7, United Kingdom
Sutton , SM2 5, United Kingdom
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