EUCTR2014-001105-41-DE进行中（未招募）1 期
A Phase 2, open-label, multicenter study to assess safety and efficacy of second/third-line treatment with nab-paclitaxel (ABI-007) in combination with epigenetic modifying therapy of CC-486, or immunotherapy of durvalumab (MEDI4736), or as monotherapy in subjects with advanced non-small cell lung cancer (NSCLC): ABOUND.2L+ - ABOUND.2L+
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy the following criteria to be randomized/assigned in the study:
- •1.Age = 18 years the time of signing the Informed Consent Form (ICF).
- •2.Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
- •3.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.
- •5.No other current active malignancy requiring anticancer therapy.
- •6.Radiographically documented measurable disease (defined by the presence of = 1 radiographically documented measurable lesion).
- •7.One prior platinum-containing chemotherapy for metastatic or recurrent NSCLC unless patients are ineligible to receive it it or if disease progressed within 6 months of a platinumcontaining neoadjuvant/adjuvant regimen. Patients may have received no more than one line of chemotherapy; immunotherapy in prior line of treatment (first or second line) is allowed.
- •8.Absolute neutrophil count (ANC) = 1500 cells/mm3.
- •9.Platelets = 100,000 cells/mm3.
- •10.Hemoglobin (Hgb) = 9 g/dL.
- •11.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.
- •12.Total bilirubin = 1.5 ULN (unless there is a known history of Gilberts Syndrome).
- •13.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).
- •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:
- •a.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.
- •b.Either commit to true abstinence* from heterosexual contact 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:
- •a.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.
- •b.Refrain from semen or sperm donation while taking durvalumab and for at least 3
- •months after the last dose of durvalumab.
- •16.Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.
- •*True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovula
排除标准
- •1. Refractory to prior taxane therapy for advanced disease (use in adjuvant setting possible if no disease recurrence within 12 months)
- •2. Evidence of active brain metastases, including leptomeningeal involvement Antiepileptic treatment is permitted in the context of prophylaxis for seizures.
- •3. Only evidence of disease is non-measurable at study entry
- •4. Known activating mutations in EGFR
- •5. Known activating mutations in EML4-ALK.
- •6. Preexisting peripheral neuropathy Grade > 2.
- •7. Unresolved toxicity Grade = 2 from previous anticancer therapy (with exceptions)
- •8. Venous thromboembolism within 1 month prior to Cycle 1 Day 1.
- •9. Current congestive heart failure (NYHA Class II-IV).
- •10. History of the following within 6 months prior to Cycle 1 Day 1: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- •11. Known hepatitis B or C virus infection, known history of HIV infection, or receiving immunosuppressive or myelosuppressive medications that would increase the risk of serious neutropenic complications, history of active primary immunodeficiency, active tuberculosis
- •12. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •13. History of interstitial lung disease, of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. Any lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- •14. Clinically significant malabsorption syndrome, persistent diarrhea, or known sub-acute bowel obstruction > Grade 2, despite medical management.
- •15. Treatment with any chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment within 28 days prior to signing the ICF.
- •16. History of or suspected allergy to any IP or their excipients.
- •17. Major surgical procedure within 28 days prior to the first dose of IP.
- •18. Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
- •19. Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of IP according to this protocol or which, in the views of Investigator, preclude combination chemotherapy.
- •20. Any other malignancy within 5 years prior to randomization/treatment assignment, or advanced malignant hepatic tumors (with exceptions)
- •21. 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 target lesion permitted only if there has been clear progression of the lesion since radiation was completed.
- •22. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •23. Any medical condition that confounds the ability to interpret data from the study.
- •24. Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screeni
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