NL-OMON50938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 20 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
- 20
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
- •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
- •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 *1500/µL
- •* Platelets *100,000/µL
- •* Hemoglobin *9 g/dL
- •* Aspartate aminotransferase/alanine aminotransferase *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
- •* International normalized ratio (INR) and activated partial thromboplastin
- •time (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
- •* 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.
- •10. Men must agree to use contraception or practice abstinence as well as
- •refrain from donating sperm during the treatment period and for at least 180
- •days after the last dose of study treatment.
- •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 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
- 另有 5 项未显示
排除标准
- •1. Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer
- •therapy (e.g., monoclonal antibody 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 study treatment
- •or 5 half-lives, whichever is longer without recovery of clinically significant
- •toxicities from that therapy.
- •4. Any of the following tumor locations/types:
- •* NSCLC involving the superior sulcus
- •* Large cell neuro-endocrine cancer
- •* Sarcomatoid tumor
- •5. Tumors known to express driver mutations of the EGFR or ALK pathways.
- •Patients whose driver mutation status is unknown may enroll in the study and
- •their tissue will be checked after enrollment. The SAP will describe how the
- •subset of patients who are subsequently found to have one of the 2 drive
- •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/solid 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 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 Exclusion 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
- 另有 4 项未显示
研究者
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