JPRN-jRCT2080224593招募中3 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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main Cohort Key Inclusion Criteria:
- •1. Age 18 years or more
- •2. Planned SoC SBRT as definitive treatment
- •3. WHO/ECOG PS of 0, 1 or 2
- •4. Life expectancy of at least 12 weeks
- •5. Body weight >30 kg
- •6. Submission of tumor tissue sample if available
- •7. Adequate organ and marrow function required
- •8. Patients with central or peripheral lesions are eligible
- •9. Staging studies must be done during screening (PET-CT within
- •10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
- •Osimertinib Cohort Key Inclusion Criteria
- •1. Age 18 years or more
- •2. Planned SoC SBRT as definitive treatment
- •3. World Health Organization (WHO)/ECOG PS of 0, 1, or 2
- •4. Patients with central or peripheral lesions are eligible
- •5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
- •6. Staging studies must be done during screening (PET-CT within 10 weeks)
- •7. Submission of available tumor tissue sample
- •8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
- •9. Adequate bone marrow reserve or organ function required
- •10. Female patients should be using highly effective
- •contraceptive measures
- •11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation
排除标准
- •Main Cohort Key Exclusion Criteria:
- •1. Mixed small cell and non-small cell cancer
- •2. History of allogeneic organ transplantation
- •3. History of another primary malignancy with exceptions
- •4. History of active primary immunodeficiency
- •5. Epidermal growth factor receptor local testing is mandated prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
- •6. Prior exposure to immune-mediated therapy with exceptions
- •Osimertinib Cohort Key Exclusion Criteria
- •1. Mixed small cell and non-small cell cancer
- •2. Patients currently receiving potent inducers of CYP3A4
- •3. Patients with known or increased risk factor for QTc prolongation
- •4. 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
- •5. 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
- •6. 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 with 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: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002572-41-PLAstraZeneca AB690
招募中
3 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)non small-cell lung cancer10038666lung cancerNL-OMON54495Astra Zeneca8
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