Stereotactic Body Radiotherapy（SBRT） for Oligo-Progression During the First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer（OPPRESS）： A Prospective, Randomized, Controlled, Open Label, Multi-Center Phase 3 Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:
Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?
Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.
Participants will:
Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.
详细描述
This study is a prospective, randomized, controlled, open, multicenter phase Ⅲ study of patients with stage IV NSCLC who developed oligo-progression after ≥3 months of disease stabilization obtained with first-line chemotherapy, aiming to evaluate the efficacy and safety of applying SBRT to treat oligo-progressive NSCLC after first-line chemotherapy.
NSCLC patients with oligo-progression (≤5 extracranial progression sites) after ≥3 months of disease stabilization by first-line systemic therapy and who are suitable for SBRT will be screened to meet the enrollment criteria after signing the informed consent and will be randomized to the SBRT/SOC groups according to the stratification ratio of 1:1.
SBRT group: SBRT was performed on the progressed sites while maintaining the original regimen of treatment. Evaluation was performed after completion of SBRT treatment, and if disease progression that was no longer suitable for SBRT treatment occurred, the second-line systemic treatment regimen with docetaxel/albumin-bound paclitaxel as the mainstay was switched.
SOC group: undergo a second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years. Gender is not limited.
- •Histologically and/or cytologically confirmed stage IV metastatic NSCLC.
- •Eastern Cooperative Oncology Group (ECOG) score of 0-
- •Patients have received first-line chemotherapy and have had stable disease for ≥3 months.
- •Patients with driver gene-negative NSCLC who experience oligo-progression during treatment with first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Patients with driver gene positivity, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, who experienced oligo-progression during treatment with first-line chemotherapy in combination with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy may also be included in the study.
- •Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography / computertomography (PET/CT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.
- •All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.
- •Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the 5 oligo-progressive sites.
- •Expected survival time greater than 3 months.
- •Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count/differential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.
- •Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.
- •Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.
排除标准
- •Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.
- •Pregnant or lactating women.
- •Prior history of SBRT/SABR treatment.
- •More than 5 sites of progression.
- •Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.
- •Presence of untreated intracranial metastases or symptomatic progressive sites.
- •History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.
- •Serious active comorbidities that would interfere with treatment in this study.
- •History or evidence of disease that could interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal values of treatment or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate.
研究组 & 干预措施
SBRT arm
SBRT is administered to the site of progression. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC).
干预措施: Stereotactic Body Radiotherapy (Radiation)
SBRT arm
SBRT is administered to the site of progression. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC).
干预措施: second-line systemic therapy (Drug)
SOC arm
Second-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable.
干预措施: second-line systemic therapy (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first, assessed up to 18 months.
Progression-free survival, PFS: Time from date of randomization until the date of first documented progression or date of death from any cause after the second-line treatment, whichever came first.
次要结局
- Overall Survival (OS)(Time from date of randomization to death (from any cause), assessed up to 36 months.)
- Quality of Life (QoL)(From enrollment to the end of survival follow-up at 36 months.)
- Safety of SBRT(From enrollment to the end of treatment at 4 weeks)