KCT0005588招募中未知
A randomised non-comparative open label phase II trial of atezolizumab plus bevacizumab, with carboplatin-paclitaxel or pemetrexed, in EGFR mutant non-small cell lung carcinoma with acquired resistance
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •7.1.1. Patients (male/female) must be =18 years of age.
- •7.1.2. Chemotherapy naïve, non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy)
- •or stage IV according to 8th TNM classification. Patients who have received previous
- •adjuvant or neoadjuvant chemotherapy are eligible if the date of last dose of treatment was at
- •least 12 months before randomisation
- •7.1.3. Known EGFR mutations genotypes by tissue or ctDNA; patients with common mutations
- •(L858R or Del19) and other rare mutations (e.g. S768I, G719X) are eligible
- •7.1.4. Measurable or evaluable disease as defined by RECIST v1.1
- •7.1.5. Disease progression (during or after) or unacceptable side effects from prior treatment with at
- •least one EGFR TKI (washout period = 7 days).
- •If most recent line of treatment (1st or 2nd line) was a third-generation EGFR TKI (e.g. osimertinib):
- •– Patient must be known to be EGFR mutation positive, either on fresh tumour biopsy taken >7
- •days prior to protocol treatment start or by recent ctDNA analysis (informative ctDNA test,
- •local test).
- •– T790M genotype is allowed
- •If most recent line of treatment (1st or 2nd line) was a first- or second-generation EGFR TKI (e.g.
- •afatinib, dacomitinib, erlotinib, gefitinib):
- •– Patient must be known to be tissue EGFR T790M wild type (local test) on most recent line of
- •EGFR TKI or if no tissue re-biopsy, no evidence of T790M on ctDNA but identified L858R,
- •del19, S768I or G719X genotypes (informative ctDNA test, local test)
- •7.1.6. Treatment with an EGFR TKI therapy for at least 10 days
- •7.1.7. Adequate haematological function:
- •Haemoglobin ?90 g/L
- •ETOP 15-19 ABC-lung protocol v1.0 20191031 37/126
- •Absolute neutrophils count (ANC) ?1.5× 109
- •Platelet count ?100× 109
- •7.1.8. Adequate renal function:
- •Creatinine ?1.5× ULN OR
- •Creatinine clearance ?45 mL/min (using the Cockcroft-Gault formula below):
- •Cockcroft-Gault formula
- •(140-age[years])×actual body weight [kg]
- •72×Creatinineserum (
- •(×0.85 if female)
- •7.1.9. Adequate liver function:
- •ALT and AST ?2.5× ULN. If the patient has liver metastases, ALT and AST must be =5×
- •Total bilirubin ?1.5x ULN. If the patient has liver metastases or documented Gilbert’s
- •syndrome (unconjugated hyperbilirubinaemia) ?3x ULN.
- •7.1.10. Willingness to provide any surplus tumour sample obtained at the time of acquired resistance
- •to prior EGFR TKI
- •7.1.11. Men and women of childbearing potential must agree to use adequate contraception
- •7.1.12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •7.1.13. Life expectancy ?12 weeks
- •7.1.14. Women of childbearing potential, including women who had their last menstrual period in the
- •last 2 years, must have a negative serum or urine pregnancy test within 7 days before
- •randomisation.
- •7.1.15. Patient is willing and able to comply with the protocol for the duration of the trial including
- •undergoing treatment and scheduled visits and examinations including follow up.
排除标准
- •7.2.1. Prior systemic cytotoxic chemotherapy for advanced stage NSCLC.
- •Patients who had received previous adjuvant or neoadjuvant chemotherapy are eligible if the
- •last dose of treatment was at least 12 months before randomisation.
- •7.2.2. Prior therapy with bevacizumab or other anti-angiogenic agent
- •ETOP 15-19 ABC-lung protocol v1.0 20191031 38/126
- •7.2.3. Prior immune checkpoint inhibitor therapy
- •7.2.4. More than two lines of EGFR TKI therapy
- •7.2.5. Known small-cell lung carcinoma (SCLC) or high grade neuroendocrine carcinoma (if
- •progression biopsy has been performed locally).
- •7.2.6. Squamous cell histologic subtype
- •7.2.7. Known EGFR T790M positive genotype by tissue on most recent EGFR TKI progression or
- •ctDNA and have not received an approved EGFR TKI targeting T790M (e.g. a thirdgeneration
- •EGFR TKI such as osimertinib).
- •7.2.8. Active or untreated CNS metastases as determined by brain MRI
- •– Patients with CNS metastases must be non-progressive by RECIST and
- •symptomatically stable with no ongoing requirement for corticosteroids as therapy
- •for CNS disease; anticonvulsants at a stable dose allowed
- •7.2.9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation
- •within 4 weeks of randomization.
- •7.2.10. Presence or history of a malignant disease that has been diagnosed and/or required therapy
- •within the past 3 years. Exceptions to this exclusion include the following: completely
- •resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ
- •of any type.
- •7.2.11. Clear tumour infiltration into the thoracic great vessels (seen on imaging)
- •7.2.12. QTc of grade =3 according to CTCAE v5.0
- •7.2.13. Active autoimmune disease that has required systemic treatment in past 2 years. Patients with
- •vitiligo, controlled type I diabetes mellitus on stable insulin, or residual autoimmune-related
- •hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic
- •treatment are permitted
- •7.2.14. Active or uncontrolled HIV, tuberculosis, hepatitis B or C infection
- •7.2.15. Live attenuated vaccination within 4 weeks prior to randomisation.
- •7.2.16. Subject receiving any biologic drugs targeting the immune system (for example, TNF
- •blockers, anakinra, rituximab, abatacept, or tocilizumab).
- •ETOP 15-19 ABC-lung protocol v1.0 20191031 39/126
- •7.2.17. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis,
- •idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed
- •tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •7.2.18. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or
- •diastolic blood pressure >100 mmHg)
- •– Anti-hypertensive therapy to achieve these parameters is allowable.
- •7.2.19. Prior history of hypertensive crisis or hypertensive encephalopathy
- •7.2.20. Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral
- •arterial thrombosis) within 6 months prior to randomization
- •7.2.21. History of haemoptysis (?2.5mL of bright red blood per episode) within 1 month prior to
- •randomization
- •7.2.22. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- •7.2.23. Current or recent (within 10 days of randomization) use of aspirin (>325 mg/day) or treatment
- •with dipyramidole, ticlopidine, clopidogrel, and clostazol
- •7.2.24. Current use
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