KCT0005379终止未知
Phase II, single-arm study of AZD2811 and Durvalumab (MEDI4736) combination therapy in relapsed small cell lung cancer subjects [SUKSES-N5]
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1. Provision of fully informed consent prior to any study specific procedures.
- •2. Subjects must be = 18 years of age.
- •3. Body weight > 30kg
- •4. Small cell lung cancer that has progressed during or after first-line therapy.
- •a. The 1st line regimen must have contained platinum based regimen and must have documented radiological and/or clinical progression on treatment.
- •b. Refractory to first-line chemotherapy or relapse within 6 months since the last dose of first-line chemotherapy
- •c. If the subject has sensitive relapse (relapse more than 6 months since the last dose of first-line chemotherapy), (s)he should receive second-line treatment prior to study entry.
- •5. Histologically confirmed SCLC with documented c-MYC expression [ = c-MYC IHC 1+]
- •6. Subjects are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •7. ECOG performance status 0-1
- •8. Subjects must have a life expectancy = 3months from proposed first dose date.
- •9. Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- •a. Haemoglobin = 9.0g/dL)
- •b. White blood cells (WBC) = 3 x 109/L
- •c. Platelet count = 100 x 109/L
- •d. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •e. Total bilirubin = 1.5 x institutional upper limit of normal (ULN)
- •f. Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be = 5x ULN
- •g. Subjects must have serum creatinine (CR) =1.5 times the normal upper limit of the
- •study institution or creatinine clearance estimated using the Cockcroft-Gault equation of = 45 mL/min:
- •Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a
- •serum creatinine (mg/dL) x 72
- •a where F=0.85 for females and F=1 for males.
- •10. At least one measurable lesion that can be accurately assessed at baseline by imaging or
- •physical examination at baseline and is suitable for repeated assessment.
- •11. Postmenopausal or evidence of non-childbearing status for women of childbearing
- •Potential or a negative urine or serum pregnancy test at screening and confirmed prior to
- •treatment on Day 1 of every cycle
- •Postmenopausal is defined as:
- •a. Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- •b. Luteinizing hormone(LH) and Follicle stimulating hormone(FSH) levels in the post menopausal range for women under 50
- •c. Radiation-induced oophorectomy with last menses >1 year ago
- •d. Chemotherapy-induced menopause with >1 year interval since last menses
- •e. Surgical sterilisation(bilateral oophorectomy or hysterectomy)
- •12. Male and women of childbearing portential , who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 6 months after last dose of investigational product(s) to prevent pregnancy in a partner.
- •13. Provision of tumor sample (from either archival and/or fresh biopsy)
- •14. Optional: Provision of separate informed consent for genetic research.
- •If a subject declines to participate in the genetic research, there will be no penalty or loss of benefit to the subject. The subject will n
排除标准
- •1. Previous enrolment in the present study or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- •2.More than two prior chemotherapy regimens for the treatment of small cell lung cancer refractory to first-line chemotherapy or relapse within 6 months.
- •(However, immunotherapy is not counted the prior chemotherapy regimen.)
- •3.Subjects with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 2 years. Or patients with a history of leptomeningeal carcinomatosis.
- •4. Treatment with any investigational product during the last 14 days before the first dose on study.
- •5. Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The subject can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
- •6. Receiving, or having received, concomitant medications, herbal supplements and/or foods
- •that significantly modulate cytochrome P450 3A4(CYP3A4) or P-glycoprotein(P-gp)
- •activity (washout periods of 2 weeks, but 3 weeks for St. John’s Wort). Note these include
- •common azole antifungals, macrolide antibiotics and other medications.
- •7. Prior exposure to an AURKB inhibitor or PD-1 or PD-L1 or CTLA-4 inhibitor.
- •8. Current or prior use of immunosuppressive medication within 14 days before the
- •first dose of durvalumab. The following are exceptions to this criterion:
- •a. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
- •b. Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent
- •c. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- •9. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product. Note: Subjects, if enrolled, should not receive live vaccine whilst receiving investigational product and up to 180 days after the last dose of investigational product.
- •10. Any unresolved toxicity NCI CTCAE grade=2 from previous anticancer therapy
- •with the exception of alopecia, vitilgo, and the laboratory values defined in the inclusion
- •criteria (CTCAE version 5.0)
- •a. Subjects with Grade =2 neuropathy will be evaluated on a case-by-case basis after
- •consultation with the Investigator.
- •b. Subjects with irreversible toxicity not reasonably expected to be exacerabated by
- •treatment with durvalumab may be included only after consultation with with the
- •Investigator.
- •11. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
- •within 4 weeks before the enrollment.
- •12. Haematuria: +++ on microscopy or dipstick
- •13. INR = 1.5 or other evidence of impaired hepatic synthesis function
- •14. Subject has any of the following cardiac criteria:
- •a. Mean QT interval corrected for heart rate(QTcF) = 470ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s correction.
- •b. Any clinically important abnormalities in rhythm, conduction or morphology of resting
- •ECG eg, complete left bundle branch block, third
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