2023-504112-15-00已完成2 期
A Phase 2 Open-label Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs leading to discontinuation, AEs of special interest (AESI), deaths and laboratory abnormalities. Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
研究概览
简要总结
- To assess safety and tolerability of MORAb-202 in participants with previously treated, metastatic non-small cell lung cancer (NSCLC) adenocarcinoma (AC)
- To assess tumor response of MORAb-202 in participants with previously treated, metastatic NSCLC AC
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants or legally acceptable representatives who signed Written Informed Consent
- •Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization.
- •Participants (male or female) must be 18 years or older at the time of signing the informed consent
- •Participants with histologically or cytologically documented metastatic NSCLC adenocarcinoma (AC)
- •Investigator-assessed radiologically documented disease progression during or after last treatment
- •Measurable target disease assessed by the investigator according to RECIST 1.
- •Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of disease progression based on RECIST 1.1 to be deemed a target lesion
- •ECOG PS of 0 or 1
- •Participants must have received prior treatment, including platinumbased chemotherapy and: i) If without actionable genetic alterations or unknown genetic alterations status, treatment with anti-PD-1/PD-L1 OR ii) If with known actionable genetic alterations, treatment with at least 1 targeted therapy
- •Participants must have received no more than 3 prior lines of systemic therapy in the metastatic setting NOTE: Participants with resectable or stage 3 locally advanced disease that has recurred or progressed within 1 year from the start of treatment with platinumbased chemotherapy and anti-PD-1/PD-L1 are not required to be retreated in the metastatic setting to be eligible.
排除标准
- •Medical Conditions -NSCLC histologies other than adenocarcinoma (AC) -Not applicable per Protocol Amendment 2 : Pulmonary Function Test (PFT) abnormalities -Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment -Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented >6 months before starting study treatment -Current infectious pneumonia (including COVID-19-related infection), history of viral pneumonia with evidence of persistent radiologic abnormalities -Investigator assessed current ILD/pneumonitis or ILD/pneumonitis is suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy -Participants with an active, known or suspected autoimmune disease, connective tissue, or inflammatory disorders with documented pulmonary involvement
- •Prior/Concomitant Therapy -Participants who have received prior investigational treatment with FRα-targeting agent, or FRα-targeting ADCs including MORAb-
- •Any condition requiring folate supplementation (eg, folate deficiency). -Any major surgery within 4 weeks of the first dose of study treatment
- •Physical and Laboratory Test Findings -Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
研究组 & 干预措施
farletuzumab ecteribulin
Experimental
Participants receiving farletuzumab ecteribulin
干预措施: farletuzumab ecteribulin (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs leading to discontinuation, AEs of special interest (AESI), deaths and laboratory abnormalities. Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs leading to discontinuation, AEs of special interest (AESI), deaths and laboratory abnormalities. Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
次要结局
- Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs of special interest (AESI), deaths and laboratory abnormalities.
- PFS by RECIST 1.1 per investigator assessment
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (11)
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