NL-OMON52295尚未招募2 期
Dual-immunotherapy and short-course medium-dose radiotherapy, followed by surgery for tumor microenvironment modification in early-stage NSCLC - DIRECT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 12
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
- •1. Histologically confirmed NSCLC
- •2. T1c-3N0-2, here T3 tumors are based on size, but not based in invasion into
- •the thoracic wall, mediastinum, vertebra or diaphragm or ipsilateral lung
- •3. Willing and able to provide written informed consent for the trial
- •4. Above 18 years of age on day of signing informed consent
- •5. Have measurable disease based on RECIST 1.1. [18]
- •6. Have a ECOG performance status of 0-1, and are considered operable based on
- •pulmonary function test and/or exercise testing
- •7. Demonstrate adequate organ function, as deemed acceptable by the treating
- •physician in the context of immunotherapy:
- •a. Leukocytes >= 3,000/mm3
- •b. Absolute neutrophil count (ANC) >= 1000/mm3
- •c. Platelet count >= 75,000/mm3
- •d. Hemoglobin >= 6 mmol/L (9.7 g/dL)
- •e. Creatinine <= 1.5 x ULN or creatinine clearance (CrCl) >=40 mL/min (if using
- •the Cockcroft-Gault formula below):
- •i. Female CrCl = [(140 - age) x weight x 0.85]/(0.85 x creat in mmol/L)
- •ii. Male CrCl = [(140 - age) x weight x 1.00]/(0.81 x creat in mmol/L)
- •f. Total Bilirubin <= 1.5 x ULN (except subjects with Gilbert Syndrome)
- •g. AST and ALT <= 2.5 times the upper limit of normal
- •h. Subjects must have adequate lung function to permit surgical resection
- •determined by pre-enrollment pulmonary function tests to include DLCO
- •8. Body weight >30 kg
- •9. Must have a life expectancy of at least 12 weeks
排除标准
- •1. Prior surgery and/or radiotherapy on the ipsilateral thorax 2. Patients
- •deemed inoperable 3. Subjects with a condition requiring systemic treatment
- •with either corticosteroids (>10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of day 0. Inhaled or topical
- •steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent,
- •are permitted in the absence of active autoimmune disease. 4. Additional
- •malignancy that is progressing or requires active treatment. Exceptions include
- •basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in
- •situ cervical cancer that has undergone potentially curative therapy. 5. Active
- •or prior documented autoimmune or inflammatory disorders (including
- •inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis
- •[with the exception of diverticulosis], systemic lupus erythematosus,
- •Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis,
- •Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The
- •following are exceptions to this criterion: • Patients with vitiligo or
- •alopecia • Patients with hypothyroidism (e.g., following Hashimoto syndrome)
- •stable on hormone replacement • Any chronic skin condition that does not
- •require systemic therapy • Patients without active disease in the last 5 years
- •may be included but only after consultation with the study physician • Patients
- •with celiac disease controlled by diet alone 6. Uncontrolled intercurrent
- •illness, including but not limited to symptomatic congestive heart failure,
- •uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia,
- •interstitial lung disease, serious chronic gastrointestinal conditions
- •associated with diarrhea, or psychiatric illness/social situations that would
- •limit compliance with study requirement, substantially increase risk of
- •incurring AEs or compromise the ability of the patient to give written informed
- •consent 7. Active infection requiring systemic therapy. 8. A history of Human
- •Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 9. Active infection
- •including tuberculosis (clinical evaluation that includes clinical history,
- •physical examination and radiographic findings, and TB testing in line with
- •local practice), hepatitis B (known positive HBV surface antigen (HBsAg)
- •result), hepatitis C, Patients with a past or resolved HBV infection (defined
- •as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg)
- •are eligible. Patients positive for hepatitis C (HCV) antibody are eligible
- •only if polymerase chain reaction is negative for HCV RNA. 10. Psychiatric or
- •substance abuse disorders that would interfere with cooperation with the
- •requirements of the trial. 11. Has received prior therapy with an anti-PD-1,
- •anti-PD-L1 including durvalumab, anti-PD-L2, anti-CTLA-4 antibody, or any other
- •antibody or drug specifically targeting T-cell co-stimulation or immune
- •checkpoint pathways. 12. Patient is pregnant or breastfeeding, or expecting to
- •conceive within the projected duration of the trial, starting with the
- •pre-screening or screening visit through 23 weeks after the last dose of trial
研究者
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