NL-OMON44296已完成不适用
Phase 1b study of safety and tolerability in patients treated with stereotactic radiotherapy combined with durvalumab and tremelimumab in stage 4 NSCLC - SBRT + durvalumab + Tremelimumab in NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
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
- •- Written informed consent;
- •- Histologically confirmed stage IIIB (without curative treatment options) and stage IV NSCLC. Tumor mutation status must be known, analyzed by next generation sequencing for specific mutations;
- •- A tumour tissue sample (< 6 month old);
- •- Any line of previous chemotherapy (but at least 1 line), with washout period of at least 4 weeks;
- •- At least one unidimensionally measurable lesion according to RECIST1.1 criteria;
- •- Age * 18 years;
- •- ECOG / WHO performance status of 0 or 1;
- •- Life expectancy of *12 weeks;
- •- Body weight > 30 kg;
- •- Adequate normal organ and bone marrow function:
- •- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
- •- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •- Women * 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >;1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •- Subject is willing and able to comply with the protocol for the duration of the study;
- •- Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
排除标准
- •- Involvement in the planning and/or conduct of the study
- •- Participation in another clinical study with an investigational product during the last 3 months.
- •- 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.
- •- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) 1 month prior to the first dose of study drug (wash out period).
- •- Primary tumor smaller than 3 cm.
- •- 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.
- •- Patients with Grade * 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- •- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
- •- 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.
- •- Any history of radiotherapy treatment to the chest.
- •- Any prior radiotherapy (including palliative radiotherapy to non-target lesions) within 4 month of the first dose of study drug.
- •- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- •- History of leptomeningeal carcinomatosis
- •- Subjects with untreated CNS metastases are excluded.
- •- Active or prior documented autoimmune or inflammatory disorders
- •- Uncontrolled intercurrent illness
- •- Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
- •- History of allogenic organ transplantation.
- •- History of active primary immunodeficiency
- •- Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV. Patients with a past or resolved HBV infection and absence are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- •- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab
- •- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP
- •- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- •- Patients who have received any prior anti-PD-1, anti PD-L1 or anti CTLA-4.
- •- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- •- Judgment by the investigator that the patient is unsuitable to participate in the study
- •- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willi
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