NL-OMON56744尚未招募不适用
A performance evaluation study for the testing of DNA extracted from either tumor tissue biopsy samples or plasma, using the therascreen® EGFR Plus RGQ PCR Kit, from subjects with Non-Small Cell Lung Cancer, being screened for inclusion in Taiho Oncology, Inc*s Clinical Trial (Protocol No. 10073010). - Testing samples using the therascreen EGFR Plus RGQ PCR Kit.
QIAGE0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
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 99（—）
入选标准
- •1. Provide written informed consent
- •2. >=18 years of age (or meets the country*s regulatory definition for legal
- •whichever is greater)
- •3. Histologically or cytologically confirmed, locally advanced, non-resectable
- •or metastatic
- •4. Has received the following prior treatment and no more than 2 lines of prior
- •chemotherapy for locally advanced or metastatic disease setting:
- •a. Part A1 (Phase 1 Dose Escalation): Standard of care (SOC) that is
- •available to the
- •patient, unless contraindicated or intolerable to the patient
- •b. Part A2: Progression on third-generation EGFR TKI (eg, osimertinib,
- •lazertinib) and having received or not eligible for platinum-based
- •chemotherapies or other
- •targeted approved therapies in case of off-target alterations.
- •c. Parts B, and C: Progression on third-generation EGFR TKI (eg,
- •osimertinib,
- •lazertinib)
- •5. Has the following EGFRmt status as determined by a CLIA certified (US),
- •certified (outside of the US), or the study central laboratory based on tumor
- •plasma cfDNA:
- •a. Part A1 (Phase 1 Dose Escalation): Any EGFRmt
- •b. Parts A2, B, and C: Any sensitizing EGFRmt and a confirmed C797S EGFRmt
- •(Note: no T790M EGFRmt required)
- •6. Has tumor tissue available collected after progression on the most recent
- •systemic EGFR
- •TKI treatment in a quantity sufficient to allow for analysis of EGFRmt status
- •Sponsor*s central laboratory (optional for Part A1 only). Please refer to the
- •Manual for details.
- •7. Has measurable disease per RECIST v1.1 (optional for patients in Part A1)
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •9. Adequate organ function as defined by the following criteria:
- •a. Absolute neutrophil count (ANC) >= 1.5 × 109/L
- •b. Platelet count >= 100,000/mm3 (>= 100 × 109/L); last transfusion of blood
- •must be >=2 weeks prior to start of study treatment.
- •c. Hemoglobin >= 9.0 g/dL
- •d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=
- •3.0 × upper
- •limit of normal (ULN); if liver function abnormalities are due to
- •underlying liver
- •metastasis, AST and ALT <= 5.0 × ULN
- •e. Total bilirubin <= 1.5 × ULN, or <= 3.0 × ULN for patients with Gilbert*s
- •f. Creatinine clearance (CrCl) (calculated or measured value): >=50 mL/min.
- •calculated CrCl, use the Cockcroft-Gault formula
- •g. Potassium blood levels >=3.0 mmol/L
- •10. Women of child-bearing potential (WOCBP) must have a negative serum
- •pregnancy test
- •prior to administration of the first dose of study treatment. Female patients
- •considered to be of child-bearing potential if they are post-menopausal (no
- •12 months without an alternative medical cause) or permanently sterile
- •(hysterectomy,
- 另有 9 项未显示
排除标准
- •1.Currently receiving an investigational drug in a clinical trial or
- •participating in any other
- •type of medical research judged not to be scientifically or medically
- •compatible with this
- •2. Has received prior treatment with any of the following within the specific
- •prior to the first dose of study treatment:
- •a. Major surgery/surgical therapy for any cause within 4 weeks; the patient
- •recovered adequately from the toxicity and/or complications of the
- •intervention prior
- •to starting study treatment
- •b. Chemotherapy, biologic therapy, targeted therapy, immunotherapy, or
- •investigational
- •agents within 5 half-lives or within 4 weeks (whichever is shorter)
- •prior to the first
- •dose of study treatment. Patient must have recovered from toxicities of
- •therapy based on the Investigator*s judgement prior to starting study
- •c. No prior treatment with:
- •(i) Part A1 (Phase 1 Dose Escalation): Systemic immunotherapy (eg, PD-
- •1/PD-L1 antibody)
- •(ii) Parts A2, B, and C: Any EGFR C797S mutation-targeting agent (eg,
- •d. Radiotherapy prior to the start of study treatment within:
- •(i). 2 weeks for radiation therapy of non-thoracic regions (7 days
- •for palliative
- •radiation of single lesions)
- •(ii). 3 months for radiation therapy including thoracic region.
- •Patients must have recovered from all radiation-related toxicities, not
- •corticosteroids, and not have had radiation pneumonitis.
- •3. Have any unresolved clinically relevant toxicity of Grade >= 2 from previous
- •anti-cancer
- •treatment, except for alopecia, skin pigmentation, and Grade 2, prior
- •platinum-therapy
- •related neuropathy. Patients with chronic, but stable Grade 2 toxicities may be
- •enroll if the Investigator and Sponsor agree.
- •4. Any strong and moderate inhibitors/inducers of cytochrome P450 (CYP) 3A two
- •prior to start of therapy. If a patient is receiving strong inhibitors/inducers
- •of CYP3A , these medications and substances must be discontinued >=2 weeks prior
- •to the first dose of study treatment.
- •5. Has the following CNS metastases disease status:
- •a. Part A1 (Phase 1 Dose Escalation): Known untreated central nervous
- •system (CNS)
- •metastases, or history of uncontrolled seizures, or leptomeningeal disease.
- •with treated brain metastases are eligible if there is no evidence of
- •progression for at
- •least 4 weeks after CNS-directed treatment, as ascertained by clinical
- •examination
- •and brain imaging (MRI or CT scan) during the screening period, and they
- •stable or decreasing dose of corticosteroids for at least 2 weeks prior to
- •the first dose
- •of study treatment.
- •b. Part A2, B, and C: Spinal cord compression, symptomatic and unstable CNS
- 另有 10 项未显示
研究者
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