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临床试验/NL-OMON54495
NL-OMON54495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) - PACIFIC-4/RTOG-3515

Astra Zeneca0 个研究点目标入组 8 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
8
研究概览入排标准研究者记录与标识符相似试验

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
18 至 99（—）

入选标准

  • •Main cohort:
  • •1. Age >=18 years
  • •2. Histologically or cytologically documented Stage I to II NSCLC, with
  • •clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to
  • •receive definitive treatment with SBRT. Patients may be medically inoperable or
  • •are medically operable and refusing surgery or choosing to have SBRT
  • •(Stereotactic Body Radiation Therapy) as definitive therapy
  • •3. Planned SoC SBRT as definitive treatment
  • •4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS
  • •of 0, 1, or 2
  • •5. Life expectancy of at least 12 weeks
  • •6. Body weight > 30 kg
  • •7. Submission of available tumor sample
  • •8. Adequate organ and marrow function required
  • •9. Patients with central or peripheral lesions are eligible
  • •10. Staging must be done within 10 weeks before randomization (PET)
  • •11. Pulmonary Function Testing within 12 weeks of randomization
  • •12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated
  • •definitely with surgery only or SBRT only > 1 yr prior to enrolment are eligible
  • •Osimertinib cohort:
  • •1. Age >=18 years
  • •2. Histologically or cytologically documented Stage I to II NSCLC, with
  • •clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to
  • •receive definitive treatment with SBRT. Patients may be medically inoperable or
  • •are medically operable and refusing surgery or choosing to have SBRT
  • •(Stereotactic Body Radiation Therapy) as definitive therapy
  • •3. Planned SoC SBRT as definitive treatment
  • •4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS
  • •of 0, 1, or 2
  • •5. Life expectancy of at least 12 weeks
  • •6. Body weight > 30 kg
  • •7. Submission of available tumor sample
  • •8. Adequate organ and marrow function required
  • •9. Patients with central or peripheral lesions are eligible
  • •10. Staging must be done within 10 weeks before randomization (PET)
  • •11. Pulmonary Function Testing within 12 weeks of randomization
  • •12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated
  • •definitely with
  • •13. Local confirmation of EGFR mutation (Ex19del and/or L858R)

排除标准

  • •Main cohort:
  • •1. Mixed small cell and non-small cell cancer histology
  • •2. History of allogeneic organ transplantation
  • •3. History of another primary malignancy with exceptions
  • •4. History of active primary immunodeficiency
  • •5. Uncontrolled intercurrent illness (patients with controlled chronic
  • •obstructive pulmonary disease are allowed)
  • •6. Known allergy or hypersensitivity to any of the drugs or any of the study
  • •drug excipients
  • •7. Prior exposure to immune-mediated therapy including, but not limited to,
  • •other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand
  • •antibodies, excluding therapeutic anticancer vaccines
  • •8. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
  • •treatment. Concurrent use of hormonal therapy for non-cancer-related conditions
  • •(eg, hormone replacement therapy) is acceptable. If patient has been on
  • •adjuvant hormonal treatment for early stage breast cancer for more than 5
  • •years, and there is no evidence of recurrence, then patient is eligible with
  • •study physician discussion.
  • •9. Major surgical procedure within 28 days prior to first dose of IP
  • •10. Current or prior use of immunosuppressive medication within 14 days before
  • •the first dose of IP.
  • •11. Positive pregnancy test for pre-menopausal women
  • •12. local confirmation of EGFR mutation (Ex19del and/or L858R)
  • •Osimertinib cohort:
  • •1. Mixed small cell and non-small cell cancer histology
  • •2. Treatment with any of the following:
  • •- Preoperative (neoadjuvant) or adjuvant platinum-based or other chemotherapy
  • •the disease under investigation;
  • •- Any prior anticancer or immunological therapy, including investigational
  • •for treatment of NSCLC for the disease under investigation;
  • •- Prior treatment with neoadjuvant or adjuvant EGFR-TKI;
  • •3. History of another primary malignancy with exceptions
  • •4. Sever or uncontrolled systemic disease.
  • •5. Refractory nausea and vomiting, chronic GI diseases, inability to swallow the
  • •formulated product, or previous significant bowel resection that would preclude
  • •adequate absorption of osimertinib;
  • •6. Any of the following cardiac criteria:
  • •- Mean resting QTc > 470 msec obtained from 3 electrocardiograms (ECGs), using
  • •the screening clinic ECG machine-derived QTcF value;
  • •- Any clinically important abnormalities in rhythm, conduction, or morphology of
  • •resting ECG
  • •- Patient with any factors that increase the risk of QTc prolongation or risk of
  • •arrhythmic events, such as electrolyte abnormalities
  • •7. Past medical history of ILD, drug-induced ILD, or any evidence of clinically
  • •active ILD;
  • •8. History of hypersensitivity to active or inactive excipients of osimertinib
  • •or drugs withva similar chemical structure or class to osimertinib;

研究者

发起方
Astra Zeneca

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