NCT06731413招募中2 期
Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Occurrence of chemotherapy discontinuation due to treatment-related adverse events
研究概览
简要总结
Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.
详细描述
This is a single institution, single arm, open label phase 2 study in vulnerable or older adults (Age ≥70) with recurrent or metastatic, histologically confirmed squamous cell carcinoma or non-squamous cell carcinoma of lung without driver mutation and PD-L1 TPS < 50% to evaluate safety and tolerability of reduced dose of chemotherapy and immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
- •Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
- •No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
- •Age 70 or meeting frailty definition or above at the date of signing informed consent
- •Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
- •PD-L1 tumor proportion score (TPS) of less than 50%
- •Eastern Cooperative Oncology Group (ECOG) PS of 0-3
- •Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
- •Absolute neutrophil count (ANC) ≥ 1,000/μL
- •Platelets ≥ 75,000/μL
- •Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
- •Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
- •Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Participants with life expectancy of less than 3 months at the time of enrollment
- •Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
- •Diagnosis of interstitial lung disease
- •Creatinine clearance of <30 mL/min
- •Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
- •Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:
- •Doses less than or equal to the equivalent of prednisone 10 mg daily
- •Short courses of steroids that are discontinued prior to enrollment
- •Inhaled, intranasal and/or topical steroids
- •Dexamethasone taper for treating vasogenic edema associated with CNS disease
研究组 & 干预措施
Reduced Dose Combination Therapy
Experimental
Squamous cell histology:
- Carboplatin AUC 3 every 21 days IV for 4 cycles
- Paclitaxel 135 mg/m2 every 21 IV days for 4 cycles
- Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles
Non-squamous histology:
- Carboplatin AUC 3 every 21 days IV for 4 cycles
- Pemetrexed 375 mg/m2 every 21 IV days for 4 cycles
- Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles
干预措施: Reduced Dose of Chemotherapy and Immunotherapy (Drug)
结局指标
主要结局
Occurrence of chemotherapy discontinuation due to treatment-related adverse events
时间窗: Through completion of protocol therapy, up to 2 years
Evaluate treatment tolerability i by the number of participants that discontinue chemotherapy treatment due to treatment-related adverse events.
次要结局
- Response (complete response and partial response) per Response Evaluation Criteria in Solid Tumors(Up to 5 years)
- Overall incidence and severity of all adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0(Time of patient consent and throughout the duration of the study, including during the treatment period and for 30 days following the final dose of the study medication, up to 2 years and 1 month)
- Overall survival defined as the time from the date of first study treatment until the date of death. Overall survival (OS) will be censored on the last date a participant was known to be alive(Up to 5 years)
- Progression-free survival (PFS) measured from the date of first study treatment until the date of documented disease progression(Up to 5 years)
- Cancer related symptoms and quality of life(Baseline, Cycle 3 Day 1, Cycle 5 Day 1 Cycle 9 Day 1, EOT Visit (up to 2 years))
研究者
研究点 (2)
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