EUCTR2018-002572-41-PL进行中（未招募）1 期
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) - PACIFIC-4/RTOG-3515
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 690
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Applicable to both cohorts:
- •1. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses
- •2. Age =18 years
- •3. Histologically or cytologically documented Stage I to II NSCLC, with clinical T1 to T3N0M0 Stage I/II disease and planned to receive definitive treatment with SBRT (Stereotactic Body Radiation Therapy). Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
- •4. Planned SoC SBRT as definitive treatment
- •5. World Health Organization (WHO)/ECOG PS of 0, 1, or 2
- •6. Patients with central or peripheral lesions are eligible
- •7. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
- •8. Staging studies must be done during screening (PET-CT within 10 weeks)
- •9. Submission of available tumor tissue or cell block samples from FNA
- •Main cohort (durvalumab) specific:
- •1. Life expectancy of at least 12 weeks
- •2. Body weight >30 kg
- •3. Adequate organ and marrow function required
- •4. Pulmonary Function Testing within 16 weeks of randomization
- •Osimertinib cohort specific:
- •1. Confirmation by local laboratory that the tumor harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI
- •sensitivity (Ex19del, L858R)
- •2. Adequate bone marrow reserve or organ function required
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 633
排除标准
- •Applicable to both cohorts:
- •1. Mixed small cell and non-small cell cancer
- •2. History of another primary malignancy with exceptions
- •Main cohort specific:
- •1. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
- •2. History of allogeneic organ transplantation
- •3. History of active primary immunodeficiency or autoimmune disorders
- •4. History of non-infectious pneumonitis requiring steroids
- •5. Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- •6. Prior exposure to immune-mediate therapy
- •Osimertinib cohort specific:
- •1. Patients currently receiving potent inducers of CYP3A4
- •2. Patients with known or increased risk factor for QTc prolongation
- •3. Treatment with any of the following:
- •-Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
- •-Prior treatment with neoadjuvant or adjuvant EGFR TKI
- •-Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
- •-Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
- •4. Any of the following cardiac criteria
- •-Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
- •-Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
- •-Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age
- •in first-degree relatives or any concomitant medication known to prolong the QT interval
- •-Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
研究者
相似试验
进行中（未招募）
1 期
Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer Study of osimertinib administered after radiation therapy in patients with early stage non-small cell lung cancer harboring an EGFR mutatioMain cohort: Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer Osimertinib cohort: Open-label, Single arm for patients with unresected stage I/II, lymph done negative NSCLC harboring a sensitizing EGFR mutationMedDRA version: 21.1Level: LLTClassification code: 10029514Term: Non-small cell lung cancer NOS Class: 10029104CTIS2024-512667-31-00AstraZeneca AB690
进行中（未招募）
1 期
Study of durvalumab or placebo administered after radiation therapy for patients with early stage non-small cell lung cancerPatients with unresected Stage I/II, lymph-node negative Non-small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002572-41-ESAstraZeneca AB630
进行中（未招募）
1 期
Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancerEUCTR2018-002572-41-GBAstraZeneca AB706
进行中（未招募）
1 期
Study of durvalumab or placebo administered after radiation therapy for patients with early stage non-small cell lung cancerEUCTR2018-002572-41-ITASTRAZENECA AB706
进行中（未招募）
1 期
Study of durvalumab/placebo + chemoradiation Therapy in Patients with Locally Advanced Non-small Cell Lung CancerEUCTR2017-004397-34-HUAstraZeneca AB390