NL-OMON45880已完成不适用
CA209-759: Blood-borne biomarkers for tumor response to Nivolumab in KRAS-mutated non-small cell lung cancer, an exploratory study - Biomarkers for tumor response to PD-1 inhibitors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Histologically confirmed stage IIIB and stage IV NSCLC KRAS positive tumors only.
- •2. Available tumor tissue sample.
- •3. Prior palliative radiotherapy must have been completed at least 2 weeks prior to first dose nivolumab.
- •4. Any line of previous chemotherapy.
- •5. Nivolumab has to be the treatment that will be started.
- •6. At least one unidimensionally measurable lesion according to RECIST1.1 criteria.
- •7. Life expectancy more than 3 months.
- •8. ECOG PS 0-1.
- •9. Age18 years and older, both male and female subjects
- •10. Adequate organ functions
- •11. Signed informed consent.
- •12. Male and female patients with reproductive potential must use an approved contraceptive method,
排除标准
- •1. Previous treatment with PD-1 or PD-L1 inhibitor.
- •2. Lung cancer previously treated for an ALK translocation, EGFR mutation or BRAF mutation
- •3. Pregnant or lactating women.
- •4. Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- •5. Patients without plasma sample at baseline (before treatment).
- •6. Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- •7. Subjects with carcinomatous meningitis.
- •8. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization.
- •9. Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded 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.
- •10. Other active malignancy requiring concurrent intervention.
- •11. Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •12. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •13. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- •14. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •15. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
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