A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 192
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The primary objectives of the study are:
- To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
- To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells
The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies
详细描述
There is option to join genomics sub-study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •A patient must meet the following criteria to be eligible for inclusion in the study:
- •Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
- •Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
- •Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
- •At least 1 radiographically measureable lesion per RECIST 1.1
- •ECOG performance status of ≤1
- •Anticipated life expectancy of at least 3 months
- •Adequate organ and bone marrow function
排除标准
- •A patient who meets any of the following criteria will be excluded from the study:
- •Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
- •Active or untreated brain metastases or spinal cord compression
- •Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
- •Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
- •History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization
- •Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
- •Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
- •Another malignancy that is progressing or requires treatment
- •Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
- •Active infection requiring systemic therapy within 14 days prior to randomization
- •Prior therapy with anti-PD 1 or anti-PD L1
- •Treatment-related immune-mediated AEs from immune-modulatory agents
- •Receipt of an investigational drug or device within 30 days
- •Receipt of a live vaccine within 30 days of planned start of study medication
- •Major surgery or significant traumatic injury within 4 weeks prior to first dose
- •Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
- •Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
- •Pregnant or breastfeeding women
- •Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Standard-of-care chemotherapy
Standard-of-care chemotherapy will administered from these options:
Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
干预措施: Carboplatin (Drug)
cemiplimab
cemiplimab regimen as monotherapy as per study protocol
干预措施: cemiplimab (Drug)
Standard-of-care chemotherapy
Standard-of-care chemotherapy will administered from these options:
Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
干预措施: Pemetrexed (Drug)
Standard-of-care chemotherapy
Standard-of-care chemotherapy will administered from these options:
Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
干预措施: Paclitaxel (Drug)
Standard-of-care chemotherapy
Standard-of-care chemotherapy will administered from these options:
Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
干预措施: Cisplatin (Drug)
Standard-of-care chemotherapy
Standard-of-care chemotherapy will administered from these options:
Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From date of randomization until the date of death, assessed up to 68 months
Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
PFS as assessed by a blinded IRC using RECIST 1.1.
次要结局
- Incidence of Adverse Events (AEs)(Baseline up to 68 months after treatment)
- Incidence of serious adverse events (SAEs)(Baseline up to 68 months after treatment)
- Incidence of deaths(Baseline up to 68 months after treatment)
- Characterize the pharmacokinetics (PK) of cemiplimab(Baseline up to 68 months after treatment)
- Objective response rates (ORR)(From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months)
- Best overall response (BOR)(From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months)
- Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline up to 26 months after treatment)
- Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months)
- Measure concentrations of cemiplimab in serum(Baseline up to 68 months after treatment)
- Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)(Baseline up to 26 months after treatment)
- Incidence of laboratory abnormalities(Baseline up to 68 months after treatment)