Randomized phase III trial investigating the survival benefit of adding thoracic radiotherapy to durvalumab (MEDI4736) immunotherapy plus chemotherapy in extensive stage small-cell lung cancer - TRIPLEX

niversiteit voor Wetenschap en Technologie0 个研究点目标入组 155 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 155

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

•1. Capable of giving signed informed consent which includes compliance with the
•requirements and restrictions listed in the informed consent form (ICF) and in
•this protocol. Written informed consent and any locally required authorization
•(e.g. Health Insurance Portability and Accountability Act in the US, European
•Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal
•representative prior to performing any protocol-related procedures, including
•screening evaluations.
•2. Age > 18 years at time of study entry.
•3. ECOG performance status of 0 or 1.
•4. Body weight >30 kg.
•5. Adequate normal organ and marrow function as defined below:
•Haemoglobin >=10.0 g/dL.
•Absolute neutrophil count (ANC) >=1.5 × 109 /L
•Platelet count >=100 × 109/L
•Serum bilirubin <=1.5 x institutional upper limit of normal (ULN). This does
•not apply to patients with confirmed Gilbert*s syndrome (persistent or
•recurrent hyperbilirubinemia that is predominantly unconjugated in the absence
•of hemolysis or hepatic pathology).
•ALT (SGPT) <=2.5 x institutional upper limit of normal unless liver metastases
•are present, in which case it must be <=5 x ULN.
•Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine
•CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by
•24-hour urine collection for determination of creatinine clearance.
•6. Patient is willing and able to comply with the protocol for the duration of
•the study including undergoing treatment and scheduled visits and examinations
•including follow-up.
•7. Life expectancy of at least 3 months.
•8. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1
•target lesion (TL) at baseline. Tumor assessment by computed tomography (CT)
•scan or magnetic resonance imaging (MRI) must be performed within 28 days prior
•to randomization.
•9. At least 1 measurable lesion in the thorax which is possible to irradiate to
•30 Gy in 10 fractions.
•10. Histologically or cytologically confirmed SCLC.
•11. Stage IV disease according to the TNM v8. Patients with stage III disease
•are eligible if the disease is too widespread to be treated as limited stage
•12. Pulmonary function: FEV1 >1 L or >30 % of predicted value and DLCO
•>30 % of predicted value.
•13. Female patients of childbearing potential (postmenarcheal, not
•postmenopausal [>12 continuous months of amenorrhea with no identified cause
•other than menopause], and no surgical sterilization) should use highly
•effective contraception and take active measures to avoid pregnancy while
•undergoing systemic study therapy and for at least 5 months after the last dose.
•14. Patients with brain metastases are eligible provided they are asymptomatic
•or treated and stable on steroids and/or anticonvulsants prior to the start of

排除标准

•1. Participation in another clinical study with an investigational product
•during the last 30 days.
•2. Concurrent enrolment in another clinical study, unless it is an
•observational (non-interventional) clinical study or during the follow-up
•period of an interventional study.
•3. Previous chemo- or radiotherapy for SCLC. Patients who have undergone
•surgery, but no adjuvant therapy are eligible.
•4. Any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy
•with the exception of alopecia, vitiligo, and the laboratory values defined in
•the inclusion criteria.
•5. Patients with Grade >=2 neuropathy will be evaluated on a case-by-case basis
•after consultation with the Chief Investigator.
•6. Patients with irreversible toxicity not reasonably expected to be
•exacerbated by treatment with durvalumab may be included only after
•consultation with the Chief Investigator.
•7. Any concurrent chemotherapy, investigational product or biologic cancer
•8. Any prior checkpoint inhibitor therapy, including durvalumab.
•9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide
•field of radiation within 4 weeks of the first dose of study drugs.
•10. Immediate need for thoracic radiotherapy or bulky disease outside the
•thorax, or need for such
•radiotherapy before completion of chemo-immunotherapy
•11. Major surgical procedure within 28 days prior to the first dose of study
•drugs. Note: Local surgery of isolated lesions for palliative intent is
•acceptable.
•12. History of allogenic organ transplantation.
•13. 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:
•a. Patients with vitiligo or alopecia.
•b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
•hormone replacement.
•c. Any chronic skin condition that does not require systemic therapy.
•d. Patients without active disease in the last 5 years may be included but only
•after consultation with the Chief Investigator.
•e. Patients with celiac disease controlled by diet alone.
•14. Uncontrolled intercurrent illness, including but not limited to, ongoing or
•active infection, 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.
•15. History of another primary malignancy except for:
•a. Malignancy treated with curative intent and with no known active disease >=5
•years before the first dose of IP and of low potential risk for recurrence.
•b. Localized breast or prostate cancer treated with hormonal therapy alone.
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研究者

发起方

niversiteit voor Wetenschap en Technologie

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