A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
研究概览
简要总结
Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.
详细描述
A 2-Cohort, Phase 2, multicenter, parallel-design trial that will study patients with surgically resectable, stages I-IIIA, non-small cell lung cancer (NSCLC) . The clinical study will focus on whether FL-101 has direct anti-tumor activity when given alone prior to surgery, and if FL-101 improves the anti-tumor response when given in combination with nivolumab prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Cohort 2 will be randomized. The investigator and participants will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology.
- •≥1 radiologically measurable tumor >2cm in diameter.
- •Smoking history ≥10 pack years.
- •Available tissue block for analysis from a core needle biopsy(or similar sample)
- •High-sensitivity C-reactive protein (hsCRP) level ≥2 mg/L
排除标准
- •Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer therapy (e.g., monoclonal antibody therapy) for lung cancer.
- •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
- •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 and with recovery of clinically significant toxicities from that therapy.
- •Tumors known to express driver mutations of the EGFR or ALK pathways.
- •Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients
- •Known history of human immunodeficiency virus or active Hepatitis B or Hepatitis C infection
- •Additional Exclusion Criteria for Patients with Stage II and III Disease
- •Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
- •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
- •Known severe hypersensitivity (Grade ≥3) to nivolumab or chemotherapy agents or to any of their excipients.
研究组 & 干预措施
FL-101 Monotherapy
30 patients will receive FL-101 prior to surgery.
干预措施: FL-101 (Drug)
FL-101 + Nivolumab
30 patients will receive FL-101 and Nivolumab prior to surgery.
干预措施: FL-101 (Drug)
FL-101 + Nivolumab
30 patients will receive FL-101 and Nivolumab prior to surgery.
干预措施: Nivolumab (Drug)
Nivolumab + Placebo
30 patients will receive Nivolumab and placebo prior to surgery.
干预措施: Nivolumab (Drug)
Nivolumab + Placebo
30 patients will receive Nivolumab and placebo prior to surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
时间窗: From time of first dose to 3 months after surgery
To evaluate the tolerability, incidence and severity of AEs and SAEs graded according to NCI CTCAE v5.0 of FL-101 as monotherapy and in combination with nivolumab.
次要结局
- Objective Response Rate (ORR)(At time of surgery (around 6-8 weeks after first dose))
- Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review.(At time of surgery (around 6-8 weeks))
- Major Pathologic Response(At time of surgery (around 6-8 weeks after first dose))
- Complete Pathologic Response(At time of surgery (around 6-8 weeks after first dose))
- MRD measurement by ctDNA(From time of first dose to 3 months after surgery)