AzTrials
AzTrials

Squamous Cell Carcinoma, Non-Small-Cell LungPhase 3NCT02027428

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

A Phase 3 study testing Abraxane (Induction), Carboplatin (Induction) and Abraxane (Maintenance) in people with Squamous Cell Carcinoma, Non-Small-Cell Lung, run by Celgene at 119 sites in 5 countries.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abraxane (Induction), Carboplatin (Induction) and Abraxane (Maintenance)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
427 participants
Where
119 sitesin 5 countries
Study dates
11 Feb 2014to 1 Aug 2019
Phase
Phase 3
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

  • 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.
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  • 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:
  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

119 sites in 5 countries.

119 sites in 5 countries

United States91 sites

  • New York Oncology Hematology P.C.

    Albany, New York, 12206

  • University Cancer and Blood Center, LLC

    Athens, Georgia, 30607

  • Maine Research Associates

    Auburn, Maine, 04210

  • TX Onc, PA- Beaumont

    Beaumont, Texas, 77702-1449

  • Center For Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Eastern Maine Medical Center

    Brewer, Maine, 04412

  • Hematology and Oncology Associates, Inc.

    Canton, Ohio, 44708

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Chattanooga Oncology Hematology Care

    Chattanooga, Tennessee, 37404

  • Associates in Oncology and Hematology

    Chattanooga, Tennessee, 37421

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218

  • City of Hope Cancer Center

    Duarte, California, 91010-3000

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Erie Regional Cancer Center

    Erie, Pennsylvania, 16505

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48334

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Brooke Army Medical Center Francis Street Medical Center

    Fort Sam Houston, Texas, 78235-8200

  • Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Cancer Care Associates of Fresno Medical Group Inc

    Fresno, California, 93720

  • Palo Verde Hematology Oncology, Ltd.

    Glendale, Arizona, 85304

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Moses H. Cone Regional Cancer Center

    Greensboro, North Carolina, 27403

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • Meritus Medical Center

    Hagerstown, Maryland, 21742

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • UT Health Oncology

    Houston, Texas, 77030

  • Millenium Oncology

    Houston, Texas, 77090

  • St Mary's Medical Center

    Huntington, West Virginia, 25702

  • Clearview Cancer Institute Oncology Specialties, P.C

    Huntsville, Alabama, 35805

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202-5149

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46260

  • Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Western Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • NYU Langone Medical Center

    Lake Success, New York, 11042

  • Watson Clinic, LLP Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Norton Healthcare

    Louisville, Kentucky, 40202

  • University of Louisville, J.G. Brown Cancer Center

    Louisville, Kentucky, 40202

  • Norton Cancer Institute Louisville Oncology

    Louisville, Kentucky, 40207

  • West Virginia University, Berkeley Medical Center, Cancer and Infusion Center

    Martinsburg, West Virginia, 25401

  • Tri-County Hematology and Oncology Associates

    Massillon, Ohio, 44646

  • University of Miami Miller School of Medicine Jackson Memorial Hospital

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Clinical Trials and Research Associates

    Montebello, California, 90640

  • West Virginia University, Berkeley Medical Center, Cancer and Infusion Center

    Morgantown, West Virginia, 26506

  • Hematology-Oncology Associates of NNJ, P

    Morristown, New Jersey, 07960

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203-1632

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Beth Israel Medical Centers

    New York, New York, 10003

  • NYU Langone Medical Center

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai Medical Center

    New York, New York, 10029

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Mercy Clinic Oklahoma Communities, Inc.

    Oklahoma City, Oklahoma, 73102

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Memorial Cancer Institute West

    Pembroke Pines, Florida, 33028

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania Health Systems

    Philadelphia, Pennsylvania, 19104

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center - Cancer Pavilion

    Pittsburgh, Pennsylvania, 15232

  • Rochester General Hospital

    Rochester, New York, 14621

  • St Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Mercy Medical Research Institute

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center Albert Einstein Cancer Center

    The Bronx, New York, 10467

  • Toledo Community Oncology Program

    Toledo, Ohio, 43623

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • TX Onc Tyler Cancer Center

    Tyler, Texas, 75702

  • Kansas University Medical Center

    Westwood, Kansas, 66205

  • Cancer Center of Kansas (MAT)

    Wichita, Kansas, 67208

Other trials in United States

Germany10 sites

  • Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim

    Cologne, 51109

  • St. Antonius Hospital

    Eschweiler, 52249

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82131

  • Universitatsklinikum Halle Saale

    Halle, 06120

  • Diakoniekrankenhaus Halle

    Halle, 6114

  • Thorax Klinik

    Heidelberg, 69126

  • Universitat Des Saarlandes

    Homburg, 66421

  • Lungenklinik Lostau gGmbH

    Lostau, 39291

  • Klinik Loewenstein gGmbH

    Löwenstein, 74245

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy8 sites

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

    Avellino, 83100

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, 23100

  • Istituto Nazionale Per La Ricerca Sul Cancro

    Genova, 16132

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera San Gerardo

    Monza, 20900

  • Istituto Nazionale Tumori Regina Elena di Roma

    Roma, 00144

  • Ospedale San Vincenzo Taormina

    Taormina, 98039

Other trials in Italy

Spain8 sites

  • Intituto Catalán de Oncología de Girona

    Girona, 17007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

United Kingdom2 sites

  • Churchhill Hospital

    Oxford, OX3 7LJ

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

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)

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.

Read more

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.

Read the detailed description

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

Being tested
Abraxane (Induction), Carboplatin (Induction), Abraxane (Maintenance), Best Supportive Care (Maintenance)
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
Medical subject headings
Carcinoma, Squamous Cell, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • Abraxane (Induction)Drug

    Also called nab-paclitaxel

    100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care

  • Carboplatin (Induction)Drug

    6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion

  • Abraxane (Maintenance)Drug

    100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care

  • Best Supportive Care (Maintenance)Other

    The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents

  • Abraxane (Induction)Drug

    Also called nab-paclitaxel

    100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care

  • Carboplatin (Induction)Drug

    6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care

  • Best Supportive Care (Maintenance)Other

    The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents

Study groups in NCT02027428
Study groupRoleWhat they receive
Abraxane + Best Supportive Care (BSC)ExperimentalDosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes Abraxane plus best supportive care.
Receives: Drug: Abraxane (Induction); Drug: Carboplatin (Induction); Drug: Abraxane (Maintenance); Other: Best Supportive Care (Maintenance)
Best Supportive Care (BSC)OtherDosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes best supportive care only.
Receives: Drug: Abraxane (Induction); Drug: Carboplatin (Induction); Other: Best Supportive Care (Maintenance)

What is being measured

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

  1. Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance

    Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography [CT scan], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions.

    Measured: 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 (10)

  1. Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance

    Overall survival was defined as the duration in months between randomization and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off (01 August 2019 whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.

    Measured: From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months

  2. Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study

    Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline.

    Measured: 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

  3. Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study

    PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to 01 August 2019, whichever occurred earlier. RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of new lesions is also considered progression.

    Measured: 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

  4. Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study

    Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause. Subjects who were alive at the time of analysis had their OS censored at the date or last contact of 01 August 2019, whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.

    Measured: 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

  5. 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

    Overall response in the maintenance period was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days. Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance. The 95% CI was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. - Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease.

    Measured: For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks.

  6. Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study

    Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for >= 6 weeks according to RECIST 1.1 criteria as determined by the investigator. Only participants with a confirmed CR/PR are included in this summary. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The 95% CI was calculated using Clopper-Pearson method.

    Measured: 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

  7. Time to Confirmed Response During Induction and Over the Entire Study

    Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. Only participants with a confirmed CR or PR are included in this summary.

    Measured: 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

  8. Kaplan-Meier Estimate for Duration of Response Over the Entire Study

    Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented. Participants who did not have PD after the response were censored on the date of last tumor assessment. If a participant died before PD, the participant was censored on the date of death.

    Measured: 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.

  9. Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period

    TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator.

    Measured: Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance)

  10. Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study

    TEAE over entire study is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and before the treatment discontinuation date plus 28 days, or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator.

    Measured: 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

Timeline

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

  1. First posted6 Jan 2014 (estimated)
  2. Study start11 Feb 2014
  3. Primary completion15 Sep 2017
  4. Study completion1 Aug 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02027428
Sponsor's protocol ID
ABI-007-NSCL-003
Other IDs
2014-003804-66, 2014
Status last verified
Aug 2020
First submitted
2 Jan 2014
Last updated
17 Aug 2020
Data monitoring committee
Yes

Publications

  • Thomas M, Spigel DR, Jotte RM, McCleod M, Socinski MA, Page RD, Gressot L, Knoble J, Juan O, Morgensztern D, Isla D, Kim ES, West H, Ko A, Ong TJ, Trunova N, Gridelli C. nab-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy. Lung Cancer (Auckl). 2017 Oct 30;8:207-216. doi: 10.2147/LCTT.S138570. eCollection 2017.

    PubMed 29138610

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abraxane (Induction), Carboplatin (Induction) and Abraxane (Maintenance) in people with Squamous Cell Carcinoma, Non-Small-Cell Lung, run by Celgene at 119 sites in 5 countries.

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 24 inclusion and 14 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 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Germany, Italy, Spain, United Kingdom. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Dec 2018). 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?

Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance (time frame: 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). 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 NCT02027428, which also lists 35 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 17 Aug 2020.

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