2024-512379-10-00已完成2 期
A Phase II, Non-comparative, Open label, Multi-centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non‑Small Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen (ATLANTIC)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) (per RECIST 1.1) Timepoint(s) of evaluation of this end point For each cohort, the data cut-off for the analysis of ORR will take place approximately 24 weeks after the last patient is enrolled into each cohort.
研究概览
简要总结
Cohort 1: To assess the efficacy of MEDI4736 treatment in terms of ORR in PD-L1 positive patients [abbr. PD-L1+pts] (≥25% of tumour cells with membrane staining [abbr. Tcwmst]).
Cohort 2: To assess the efficacy of MEDI4736 treatment in terms of ORR in PD-L1+pts (≥25% of Tcwmst).
Cohort 3: To assess the efficacy of MEDI4736 treatment in terms of ORR in PD-L1+pts with ≥90% of Tcwmst.
研究设计
- 研究类型
- Interventional
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
- 是
入选标准
- •Provision of signed, written and dated informed consent prior to any study specific procedures
- •Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
- •Adequate organ and marrow function
- •Male or female aged 18 years or older
- •Patients must have EITHER • Histologically- or cytologically-documented NSCLC, OR • Recurrent or progressive disease following multimodal therapy for locally advanced disease
- •Patients must have received at least 2 prior systemic treatment regimens for treatment of NSCLC
- •Patients must have experienced disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional systemic therapy
- •Patient's tumour sample must be PD-L1 positive with ≥25% of tumour cells with membrane staining (Cohorts 1 and 2) or PD-L1 positive with ≥ 90% of tumour cells with membrane staining (Cohort 3).
- •Patients must have measurable disease
- •Life expectancy ≥12 weeks at Day 1
- •World Health Organisation (WHO) Performance Status of 0 or 1
排除标准
- •Participation in another clinical study with an investigational product (IMP) during the last 4 weeks
- •Recent major surgery within 4 weeks
- •Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment
- •Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
- •History of primary immunodeficiency
- •History of allogeneic organ transplant
- •History of hypersensitivity to MEDI4736 or any excipient
- •Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
- •Uncontrolled intercurrent illness
- •Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving MEDI4736
- •History of another primary malignancy except for: • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease • Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ.
- •Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
- •Female patients who are pregnant or breast-feeding. Male or female patients of reproductive potential who are not using an effective method of birth control
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of MEDI4736 or interpretation of patient safety or study results
- •Absence of a tumour sample (archival and recent).
- •Mixed small cell and NSCLC histology
- •Receipt of any immunotherapy, or IMP within 4 weeks prior to the first dose of study drug
- •Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- •Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
- •Any prior Grade ≥3 immune-related adverse event (irAE) while Receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- •Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
- •Receipt of radiation therapy within 4 weeks prior to starting MEDI4736, or limited field of radiation for palliation within 2 weeks of the first dose of MEDI4736
结局指标
主要结局
Objective response rate (ORR) (per RECIST 1.1) Timepoint(s) of evaluation of this end point For each cohort, the data cut-off for the analysis of ORR will take place approximately 24 weeks after the last patient is enrolled into each cohort.
Objective response rate (ORR) (per RECIST 1.1) Timepoint(s) of evaluation of this end point For each cohort, the data cut-off for the analysis of ORR will take place approximately 24 weeks after the last patient is enrolled into each cohort.
次要结局
- - Duration of response - Progression free survival - Disease control rate - Overall survival - Deep sustained response - AEs Timepoint(s) of evaluation of this end point The data cut-off for analysis of the secondary efficacy endpoints will take place approximately 8 months after recruitment ends. The final analysis of OS (secondary endpoint) will take place approximately 12 months after the last patient is enrolled into each cohort.
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancerocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)MedDRA version: 20.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864EUCTR2013-005427-16-ATAstraZeneca AB1,400
进行中（未招募）
1 期
A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancerocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)MedDRA version: 20.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864EUCTR2013-005427-16-GBAstraZeneca AB1,400
进行中（未招募）
不适用
A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung CancerEUCTR2013-005427-16-HUAstraZeneca AB700
进行中（未招募）
1 期
A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancerocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)MedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864EUCTR2013-005427-16-ESAstraZeneca AB210
进行中（未招募）
1 期
A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancerocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)MedDRA version: 21.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864EUCTR2013-005427-16-DEAstraZeneca AB1,400