2023-509774-40-00进行中（未招募）3 期
A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 185
- 试验地点
- 35
- 主要终点
- Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1)
研究概览
简要总结
- To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR).
- To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
- •Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
- •Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.
- •Have stage IV nonsquamous NSCLC.
- •Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphomakinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
- •Have measurable disease based on RECIST 1.
- •Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
- •Have a life expectancy of at least 3 months.
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)Performance Status assessed within 7 days prior to the administration of studyintervention.
- •Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- •Have adequate organ function.
排除标准
- •Has predominantly squamous cell histology NSCLC.
- •Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
- •Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
- •Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- •Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- •Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
- •Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- •Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin ,pemetrexed, or olaparib.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- •Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
- •Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
结局指标
主要结局
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Number of Participants Experiencing an Adverse Event (AE)
- Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE)
- Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30) GlobalHealth Status /Quality of Life(Items 29 and30) Scale Score
- Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
- Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
- Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
- Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 & 30) Scale Score
- Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
- Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item8) Scale Score
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
研究者
Mark Shamoun
Scientific
Merck Sharp & Dohme LLC
研究点 (35)
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