EUCTR2020-005602-26-NL进行中（未招募）1 期
A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer - Phase 2 Study of FL-101 in NSCLC
Flame Biosciences0 个研究点目标入组 90 人开始时间: 2021年6月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Patients are eligible to be included in the study only if ALL the following criteria apply:
- •1. Male and female patients =18 years of age.
- •2. Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology. Staging is based on the eighth edition of the AJCC/UICC staging system.
- •3. =1 radiologically measurable tumor >2 cm in diameter, as defined by RECIST v1.1 (Eisenhauer 2009).
- •4. Lung function capacity capable of tolerating the proposed lung surgery.
- •5. Smoking history =10 pack years.
- •6. High-sensitivity C-reactive protein (hsCRP) level =2 mg/L
- •7. Adequate organ function as defined by ALL of the following:
- •- Absolute neutrophil count (ANC) =1500/µL
- •- Platelets =100,000 /µL
- •- Hemoglobin =9 g/dL
- •- AST/ALT =2.5× upper limit of normal (ULN)
- •- Total serum bilirubin =1.5×ULN; patients with Gilbert’s disease: =3×ULN
- •- Alkaline phosphatase =2.5×ULN
- •- INR and aPTT =1.5×ULN unless the patient is on therapeutic anticoagulation
- •- Serum creatinine =1.5×ULN
- •Creatinine clearance =30 mL/min/1.73 m2 by Cockcroft-Gault estimation. The patient’s estimated CrCl will be calculated by the local laboratory (for eligibility purposes) using screening/baseline height (m), actual weight (kg), and serum creatinine:
- •Males: CrCl = ((140 – age in years) × weight (kg))/72× serum creatinine (mg/dL)
- •Females: CrCl = ((140 – age in years) × weight (kg) ×0.85)/72× serum creatinine (mg/dL)
- •8. Available tissue block for analysis from a core needle biopsy (or similar sample).
- •-Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing.
- •-Acceptable samples include core-needle biopsies for deep tumor tissue (minimum of 3 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions.
- •9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 2).
- •10. Men must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for =180 days after the last dose of study treatment. (Section 5.3).
- •11. Women may participate if not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
- •- Not a woman of childbearing potential (WOCBP)
- •- WOCBP who agrees to follow contraceptive guidance (Section 5.3) during the treatment period and for at least 180 days after the last dose of study treatment.
- •Female patients will be considered of non-reproductive potential (not a WOCBP) if they are either:
- •(1) postmenopausal (defined as at least 12 months with no menses without an alternative medical cause. In women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •(2) have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening
- •(3) have a congenital or acquired condition that prevents childbearing.
- •12. Able and willing to comply with protocol-specified requirements and to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjec
排除标准
- •1. Any prior exposure to chemotherapy, radiotherapy, or systemic anti-cancer therapy for lung cancer
- •2. Malignancies other than NSCLC within 2 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =6, and prostate specific antigen [PSA] =10 mg/mL, etc.)
- •3. Currently participating in, or has participated in, a trial of an investigational agent within 4 weeks prior to the first dose of trial treatment or 5 half-lives, whichever is longer, or without recovery of clinically significant toxicities from that therapy.
- •4. Any of the following tumor locations/types: a. NSCLC involving the superior sulcus. b. Large cell neuro-endocrine cancer. c. Sarcomatoid tumor.
- •5. Tumors known to express driver mutations of EGFR or ALK pathways. Patients whose driver mutation status is unknown may enroll in the study; tissue will be checked after enrollment. SAP will describe how patients found to have one of the 2 driver mutations will be handled.
- •6. History of non-infectious pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
- •7. Had allogenic tissue/sold organ transplant.
- •8. Known severe hypersensitivity (Grade =3) to FL-101, its active substance, or any of its excipients.
- •9. Known history of human immunodeficiency virus (HIV) or active Hepatitis B or Hepatitis C infection.
- •10. Received radiotherapy within 2 weeks of start of study treatment.
- •11. Symptomatic herpes zoster within the past 30 days, a serious bacterial infection within the past 6 months or have had other recent or ongoing signs of infections
- •12. Received a live or attenuated vaccine within 30 days prior to the first dose of study treatment.
- •13. Clinically unstable disease in any organ system despite current therapy, including, but not limited to ongoing or active infection including tuberculosis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
- •14. Use of illicit drugs or excess intake of alcohol, based on the judgement of the investigator.
- •Additional Criteria for Patients with Stage II and III Disease
- •1. Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
- •2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1.
- •- Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a 1-time dose of dexamethasone for nausea) may be enrolled.
- •- The use of inhaled corticosteroids for asthma / COPD and mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency is allowed.
- •3. Known severe hypersensitivity (Grade =3) to nivolumab or any of the study chemotherapy agents or to any of their excipients.
- •4. Active autoimmune disease that has required syst
研究者
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