NL-OMON50637撤回2 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 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Main Inclusion criteria Cohort 1
- •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
- •8. Available tissue block for analysis from a core needle biopsy (or similar
- •-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
- •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
- 另有 4 项未显示
排除标准
- •Main exclusion criteria Cohort 1:
- •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
- •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.
研究者
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