2024-512667-31-00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) Osimertinib cohort, Open-label, Single arm for patients with unresected stage I/II, lymph negative NSCLC harboring a sensitizing EGFR mutation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 56
- 主要终点
- Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR
研究概览
简要总结
Applicable to main cohort: To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with a subset of T1 to T3N0M0 NSCLC
Applicable to osimertinib cohort: To assess the efficacy of osimertinib following SoC SBRT in patients with T1 to T3N0M0 in terms of 4-year PFS
研究设计
- 分配方式
- Randomized
- 主要目的
- Post-Treatment Follow up
- 盲法
- Double (Carer, Investigator, Subject, Monitor, Analyst)
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
- 否
入选标准
- •(Applicable to both cohorts) Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses
- •(Main cohort (durvalumab) specific) Life expectancy of at least 12 weeks
- •(Main cohort (durvalumab) specific) Body weight >30 kg
- •(Main cohort (durvalumab) specific) Adequate organ and marrow function required
- •(Main cohort (durvalumab) specific) Pulmonary Function Testing within 16 weeks of randomization
- •(Osimertinib cohort specific) 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)
- •(Osimertinib cohort specific) Adequate bone marrow reserve or organ function required
- •(Applicable to both cohorts) Age ≥18 years
- •(Applicable to both cohorts) 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
- •(Applicable to both cohorts) Planned SoC SBRT as definitive treatment
- •(Applicable to both cohorts) World Health Organization (WHO)/ECOG PS of 0, 1, or 2
- •(Applicable to both cohorts) Patients with central or peripheral lesions are eligible
- •(Applicable to both cohorts) Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
- •(Applicable to both cohorts) Staging studies must be done during screening (PET-CT within 10 weeks)
- •(Applicable to both cohorts) Submission of available tumor tissue or cell block samples from FNA
排除标准
- •(Applicable to both cohorts) Mixed small cell and non-small cell cancer
- •(Osimertinib cohort specific) Patients with known or increased risk factor for QTc prolongation
- •(Osimertinib cohort specific) 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
- •(Osimertinib cohort specific) 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
- •(Applicable to both cohorts) History of another primary malignancy with exceptions
- •(Main cohort specific) Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
- •(Main cohort specific) History of allogeneic organ transplantation
- •(Main cohort specific) History of active primary immunodeficiency or autoimmune disorders
- •(Main cohort specific) History of non-infectious pneumonitis requiring steroids
- •(Main cohort specific) Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- •(Main cohort specific) Prior exposure to immune-mediate therapy
- •(Osimertinib cohort specific) Patients currently receiving potent inducers of CYP3A4
结局指标
主要结局
Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR
Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR
Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1
Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1
次要结局
- Applicable to main cohort: PFS in patients with T1 to T3N0M0 NSCLC; Overall Survival; PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1; PFS2 using local assessment; PK of durvalumab in serum; Presence of ADA for durvalumab; EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life; Safety and tolerability:AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings
- Applicable to osimertinib cohort: AEs (graded by CTCAE version 5); Laboratory studies: chemistry, hematology, and urinalysis; Clinical evaluations; ECG parametres; LVEF; WHO performance status; PFS using RECIST 1.1; OS; Site(s) of disease progression; Time to CNS progression; TTP; PFS2
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (56)
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