Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer

NCT02250326 | Completed Phase 2 Results DMC

• 2 other identifiers: ABI-007-NSCL-0062014-001105-41
• Study Type: interventional
• Target: 240
• Locations: 7 countries
• Sites: 34

Brief Summary

This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects with advanced non-small cell lung cancer (NSCLC).

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Cancer of the lung; lung neoplasm; NSCLC - non-small cell lung cancer; Nonsquamou; squamous; squamous NSCLC; Tumor; locally advanced NSCLC; metastatic NSCLC; advanced lung cancer; metastatic lung cancer; non-squamous NSCLC; lung cancer; Abraxane; ABI-007; nab-paclitaxel; albumin-bound paclitaxel; taxanes; CC-486; oral azacitidine; azacitidine; second line treatment of lung cancer; second line treatment; Celgene; abound.2L; third line treatment; durvalumab; immunotherapy; MEDI4736

Outcome Measures

Primary Outcomes (1)

• Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator

  Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.

  From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months

Secondary Outcomes (9)

• Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria

  Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel

• Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria

  Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel

• Kaplan Meier Estimate of Overall Survival (OS)

  Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period

  TEAEs were collected up to 4 weeks after receiving last dose of investigational product (IP) for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 354 weeks

• Percentage of Participants Who Discontinued Study Treatment

  Up to 30 Aug 2017 for CC-486 + nab-paclitaxel and 26 Nov 2019 for nab-paclitaxe and 20 Jul 2023 for Durva + nab-paclitaxel (up to 445 weeks)

Study Arms (3)

Combination arm: nab-paclitaxel and CC-486

EXPERIMENTAL

Subjects in the combination arm will receive nab-paclitaxel 100 mg\^/m2 intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg orally daily (QD) on Days 1 to14 of each 21-day treatment cycle

Drug: nab-paclitaxel IV; Drug: CC-486

Monotherapy arm: nab-paclitaxel IV infusion

EXPERIMENTAL

Subjects in the monotherapy arm will receive nab-Paclitaxel 100 mg/m\^2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day treatment cycle

Drug: nab-paclitaxel IV

Nab-paclitaxel and Durvalumab combination

EXPERIMENTAL

subjects in the nab-Paclitaxel/durvalumab combination arm will receive nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and durvalumab 1125 mg IV infusion over approximately 1 hour on Day 15 of each 21-day treatment cycle

Drug: nab-paclitaxel IV; Drug: Duravalumab

Interventions

nab-paclitaxel IV DRUG

nab-Paclitaxel intravenous (IV) infusion

Also known as: Abraxane, ABI-007

Combination arm: nab-paclitaxel and CC-486; Monotherapy arm: nab-paclitaxel IV infusion; Nab-paclitaxel and Durvalumab combination

CC-486 DRUG

Oral CC-486

Also known as: Oral AZA, Oral azacitidine

Combination arm: nab-paclitaxel and CC-486

Duravalumab DRUG

Nab-paclitaxel and Durvalumab combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
• \. Able to adhere to the study visit schedule and other protocol requirements. 4. Histologically or cytologically confirmed advanced NSCLC who will receive study therapy as second- or third-line of treatment for advanced disease.
• \. No other current active malignancy requiring anticancer therapy. 6. Radiographically documented measurable disease (defined by the presence of ≥ 1 radiographically documented measurable lesion).
• \. One prior platinum-containing chemotherapy for metastatic or recurrent NSCLC unless patients are ineligible to receive it. Patients may have received no more than one line of chemotherapy; immunotherapy in prior line of treatment (first or second line) is allowed. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.
• \. Platelets ≥ 100,000 cells/mm3. 9. Hemoglobin (Hgb) ≥ 9 g/dL. 10. Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine transaminase (ALT/serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 × upper limit of normal range (ULN) or ≤ 5.0 × ULN if liver metastases.
• \. Total bilirubin ≤ 1.5 ULN (unless there is a known history of Gilberts Syndrome).
• \. Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 60 mL/min (if renal impairment is suspected 24-hour urine collection for measurement is required).
• \. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 14. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 15. Females of childbearing potential \[defined as a sexually mature woman who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months)\] must:
• Have a negative pregnancy test (ß-hCG) as verified by the study doctor within 72 hours prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence\* from heterosexual contact.
• Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 3 months after discontinuation of study therapy.
• Male subjects must:
• Practice true abstinence\* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
• Refrain from semen or sperm donation while taking durvalumab and for at least 3 months after the last dose of durvalumab.
• \. Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Refractory to prior taxane therapy for advanced disease. Prior taxane used in the adjuvant setting does not exclude eligibility, provided there is no disease recurrence within 12 months upon completion of chemotherapy in that setting.
• Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if asymptomatic and clinically stable for at least 8 weeks following completion of therapy). MRI of the brain (or CT scan w/contrast) is preferred.
• Only evidence of disease is non-measurable at study entry.
• Known activating EGFR mutations (such as exon 19 deletions or L858R).
• Known activating EML4-ALK mutations.
• Preexisting peripheral neuropathy of Grade \> 2 (per NCI CTCAE v4.0).
• Venous thromboembolism within 1 month prior to Cycle 1 Day 1.
• Current congestive heart failure (New York Heart Association Class II-IV).
• History of the following within 6 months prior to Cycle 1 Day 1: 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.
• Known hepatitis B or C virus (HBV/HCV) infection, known history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications, history of active primary immunodeficiency, active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
• History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis or multiple allergies. Any lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
• Subject has a clinically significant malabsorption syndrome, persistent diarrhea, or known sub-acute bowel obstruction \> NCI CTCAE Grade 2, despite medical management.
• Treatment with any chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment within 28 days prior to signing the ICF. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.

Sponsors & Collaborators

• Celgene: lead

Study Sites (34)

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143, United States

Location

Hospital of Central Connecticut Gynecologic Oncology

New Britain, Connecticut, 06050, United States

Location

University Cancer and Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Local Institution - 603

St Louis, Missouri, 63110, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medical College - New York - Presbyterian Hospital

New York, New York, 10065, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Associates in Oncology and Hematology

Chattanooga, Tennessee, 37421, United States

Location

Millennium Oncology

Houston, Texas, 77090, United States

Location

Local Institution - 642

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 641

Montreal, Quebec, H3A 1A1, Canada

Location

Local Institution - 653

Lille, 59037, France

Location

Local Institution - 651

Saint-Herblain, 44805, France

Location

Local Institution - 652

Villejuif, 94800, France

Location

Local Institution - 664

Essen, 45122, Germany

Location

Local Institution - 663

Großhansdorf, 22927, Germany

Location

Local Institution - 661

Löwenstein, 74245, Germany

Location

Local Institution - 673

Bologna, 40138, Italy

Location

Local Institution - 674

Parma, 43126, Italy

Location

Local Institution - 672

Udine, 33100, Italy

Location

Local Institution - 693

Barcelona, 08035, Spain

Location

Local Institution - 695

Barcelona, 08916, Spain

Location

Local Institution - 692

Madrid, 28034, Spain

Location

Local Institution - 691

Madrid, 28041, Spain

Location

Local Institution - 694

Málaga, 29010, Spain

Location

Local Institution - 697

Valencia, 46014, Spain

Location

Local Institution - 696

Valencia, 46026, Spain

Location

Local Institution - 630

London, Greater London, W6 8RF, United Kingdom

Location

Local Institution - 634

Bebington, Wirral, CH63 4JY, United Kingdom

Location

Local Institution - 633

Birmingham, B9 5SS, United Kingdom

Location

Local Institution - 635

London, NW1 2BU, United Kingdom

Location

Local Institution - 636

Manchester, M23 9LT, United Kingdom

Location

Local Institution - 632

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Local Institution - 631

Oxford, OX3 7LI, United Kingdom

Location

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Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasms

Interventions

Albumin-Bound Paclitaxel; cc-486; Azacitidine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: January 7, 2015
• Primary Completion: July 17, 2017
• Study Completion: August 17, 2023
• Last Updated: September 19, 2024
• Results First Posted: August 10, 2018

Record last verified: 2024-08

Locations

US (9); IT (3); ES (7); FR (3); DE (3); GB (7); CA (2)