Clinical trial NCT02027428: 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
Official title: A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma, Non-Small-Cell Lung
Keywords: Nab-paclitaxel
Albumin bound paclitaxel
Taxanes
Maintenance trials
Celgene
Abraxane
ABI-007
NSCLC
Non-Small Cell Lung Cancer
Cancer of the Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Abound.sqm
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-01-06
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of age at the time of signing the Informed Consent Form.
2. Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
3. Able to adhere to the study visit schedule and other protocol requirements

   Disease Specific
4. Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.
5. No other current active malignancy requiring anticancer therapy.
6. Radiographically documented measurable disease at study entry (as defined by the Response Evaluation Criteria In Solid Tumors \[RECIST\] v1.1 criteria).
7. 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.
8. Absolute neutrophil count ≥ 1500 cells/mm\^3.
9. Platelets ≥ 100,000 cells/mm\^3.
10. Hemoglobin ≥ 9 g/dL.
11. 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.
12. Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
13. Creatinine ≤ 1.5 mg/dL.
14. Expected survival of \> 12 weeks for the Induction part of the study.
15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
16. 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
17. 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:

    1. agree to take a pregnancy test prior to starting study medication and throughout the study participation.
    2. 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.
18. 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.
19. 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):

1. 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).
2. Only evidence of disease is non-measurable at study entry.
3. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
4. Venous thromboembolism within 6 months prior to signing Informed Consent Form.
5. Current congestive heart failure (New York Heart Association class II-IV).
6. 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.
7. Treatment with any investigational product within 28 days prior to signing Informed Consent Form.
8. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.
9. Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.
10. Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol.
11. 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).
12. 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.
13. Pregnant and nursing females.

Primary outcomes:
measure: Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance
timeFrame: From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months
Secondary outcomes:
measure: Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance
timeFrame: From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months
measure: Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study
timeFrame: Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
measure: Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study
timeFrame: Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study
measure: Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study
timeFrame: Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months
measure: Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction
timeFrame: For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks.
measure: Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study
timeFrame: Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
measure: Time to Confirmed Response During Induction and Over the Entire Study
timeFrame: Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study
measure: Kaplan-Meier Estimate for Duration of Response Over the Entire Study
timeFrame: Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study.
measure: Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period
timeFrame: Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance)
measure: Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study
timeFrame: From Day 1 up to 01 August 2019; (maximum treatment length plus 28 days); the maximum treatment duration was 234.1 weeks for entire study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute Oncology Specialties, P.C
state: Alabama
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology, Ltd.
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: Fresno
country: United States
facility: Cancer Care Associates of Fresno Medical Group Inc
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic, LLP Center for Cancer Care and Research
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine Jackson Memorial Hospital
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute West
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center, LLC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Westwood
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas (MAT)
state: Kansas
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville, J.G. Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute Louisville Oncology
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Brewer
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Bethesda
country: United States
facility: Center For Cancer and Blood Disorders
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan Cancer Center
state: Michigan
city: Saint Joseph
country: United States
facility: St Joseph Oncology
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of NNJ, P
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology P.C.
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center Albert Einstein Cancer Center
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: Lake Success
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Centers
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Regional Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Hematology and Oncology Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Mark H. Zangmeister Center
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology and Oncology Associates
state: Ohio
city: Toledo
country: United States
facility: Toledo Community Oncology Program
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oklahoma Communities, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Erie
country: United States
facility: Erie Regional Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health Systems
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Cancer Pavilion
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Care
state: Tennessee
city: Chattanooga
country: United States
facility: Associates in Oncology and Hematology
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Beaumont
country: United States
facility: TX Onc, PA- Beaumont
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center Francis Street Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Houston
country: United States
facility: UT Health Oncology
state: Texas
city: Houston
country: United States
facility: Millenium Oncology
state: Texas
city: Tyler
country: United States
facility: TX Onc Tyler Cancer Center
state: Texas
city: Kennewick
country: United States
facility: Columbia Basin Hematology and Oncology
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Huntington
country: United States
facility: St Mary's Medical Center
state: West Virginia
city: Martinsburg
country: United States
facility: West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Eschweiler
country: Germany
facility: St. Antonius Hospital
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen Gauting
city: Halle (Saale)
country: Germany
facility: Diakoniekrankenhaus Halle
city: Halle
country: Germany
facility: Universitatsklinikum Halle Saale
city: Heidelberg
country: Germany
facility: Thorax Klinik
city: Homburg
country: Germany
facility: Universitat Des Saarlandes
city: Koln
country: Germany
facility: Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim
city: Loewenstein
country: Germany
facility: Klinik Loewenstein gGmbH
city: Lostau
country: Germany
facility: Lungenklinik Lostau gGmbH
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Avellino
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
city: Genova
country: Italy
facility: Istituto Nazionale Per La Ricerca Sul Cancro
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena di Roma
city: Taormina
country: Italy
facility: Ospedale San Vincenzo Taormina
city: Girona
country: Spain
facility: Intituto Catalán de Oncología de Girona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda, Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
city: Oxford
country: United Kingdom
facility: Churchhill Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Celgene
name: Teng Jin Ong, MD
role: STUDY_DIRECTOR
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