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

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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).

Key facts

Study ID

NCT02250326

Run by

Celgene

People needed

240

Starts

2015-01-07

Expected to finish

2023-08-17

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
• 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.
• History of or suspected allergy to any IP or their excipients.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
• Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
• Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
• Any other malignancy within 5 years prior to randomization/treatment assignement, or advanced malignant hepatic tumors, with the exception of adequately treated 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 Classification of Malignant Tumours (TNM) stage of T1a or T1b). (All treatment of which should have been completed 6 months prior to signing ICF).
• Radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting 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.
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Any medical condition that confounds the ability to interpret data from the study.
• Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.

Where it is running

• UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States
• Hospital of Central Connecticut Gynecologic Oncology — New Britain, Connecticut, United States
• University Cancer and Blood Center, LLC — Athens, Georgia, United States
• Local Institution - 603 — St Louis, Missouri, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Weill Cornell Medical College - New York - Presbyterian Hospital — New York, New York, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Associates in Oncology and Hematology — Chattanooga, Tennessee, United States
• Millennium Oncology — Houston, Texas, United States
• Local Institution - 642 — Ottawa, Ontario, Canada
• Local Institution - 641 — Montreal, Quebec, Canada
• Local Institution - 653 — Lille, France
• Local Institution - 651 — Saint-Herblain, France
• Local Institution - 652 — Villejuif, France
• Local Institution - 664 — Essen, Germany
• Local Institution - 663 — Großhansdorf, Germany
• Local Institution - 661 — Löwenstein, Germany
• Local Institution - 673 — Bologna, Italy
• Local Institution - 674 — Parma, Italy
• Local Institution - 672 — Udine, Italy
• Local Institution - 693 — Barcelona, Spain
• Local Institution - 695 — Barcelona, Spain
• Local Institution - 692 — Madrid, Spain
• Local Institution - 691 — Madrid, Spain
• Local Institution - 694 — Málaga, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.