EUCTR2021-006958-31-FR进行中（未招募）1 期
An Interventional and Translational Study investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C - CODEBREAK-IGR
Gustave Roussy0 个研究点目标入组 40 人开始时间: 2022年4月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- Interventional
入排标准
- 性别
- All
入选标准
- •- Age = 18 years;
- •- ECOG = 1 at the time of screening;
- •- Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted);
- •- Subjects will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
- •- Life expectancy of > 3 months from the time of screening, in the opinion of the investigator;
- •- Patients must have lesions easily accessible to biopsy and must have accepted to perform pre-treatment, on-treatment and end-of-treatment biopsies;
- •- Have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to registration, defined as:
- •Platelet count: =100 000/mm3 or =100 × 109/L (platelet transfusions are not allowed up to 14 days prior to registration to meet eligibility)
- •Hemoglobin (Hgb): =9.0 g/dL (transfusion and/or growth factor support is allowed)
- •Absolute neutrophil count (ANC): =1500/mm3 or =1.5 × 109/L (use of growth factors is not allowed in the 14 days prior to registration)
- •Serum creatinine (SCr): SCr =1.5 times (x) the upper limit of normal (ULN), OR estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation =30 mL/min/1.73 m²
- •Liver function: a) Aspartate aminotransferase (AST) and, alanine aminotransferase (ALT) = 2.5 times the upper limit of normal (ULN), except if alkaline phosphatase > 2.5 times the ULN, then AST and/or ALT must be = 1.5 times the ULN ; b) Serum bilirubin =1.0 x ULN (<3 × ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinemia))
- •Serum albumin: =2.5 g/dL
- •Prothrombin time (PT) or Prothrombin time international normalized ratio (PT-INR) and activated partial thromboplastin time(aPTT)/partial thromboplastin time (PTT): =1.5 × ULN, except for patients on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator
- •- Patients must understand, sign and date the written informed consent from prior to any protocol-specific procedures performed.
- •- Patients should be able and willing to comply with study visits and procedures as per protocol.
- •- Patients must be affiliated to a Social Security System or beneficiary of the same.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Patient unwilling to participate to the biological investigations and to perform biopsies and blood sample collection as required in the protocol
- •- Use of known cytochrome P450 (CYP) 3A4 or P-gp sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to registration, that was not reviewed and approved by the principal investigator
- •- Use of strong inducers of CYP3A4 (including herbal supplements such as St. John’s wort) within 14 days or 5 half-lives (whichever is longer) prior to registration, that was not reviewed and approved by the principal investigator
- •- Inadequate washout period prior to registration, defined as: Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study <14 days or 5 half-lives
- •- Prior treatment with a KRAS inhibitor
- •- Major surgery within 28 days of registration
- •- Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication
- •- Significant cardiovascular disease, such as NYHA cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias or unstable angina
- •- Severe infections within 2 weeks prior to registration, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia. Prophylactic antibiotics are allowed
- •- Baseline or unresolved pneumonitis from prior treatment
- •- Current CTCAE v5.0 grade = 2 peripheral neuropathy
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Subjects with PleurX catheters in place may be considered for the study with Principal Investigator approval
- •- Known history of HIV infection
- •- Exclusion of hepatitis infection based on the following results and/or criteria:
- •a) Positive HepBsAg (indicative of chronic or recent acute hepatitis B)
- •b) Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B core antibody testing is not required for screening, however if this is done and is positive, then hepatitis B surface antibody [Anti-HBs] testing is necessary. Undetectable anti-HBs in this setting would suggest unclear and possible infection, and needs exclusion).
- •c) Positive Hepatitis C virus antibody: Hepatitis C virus RNA by PCR is necessary. Detectable Hepatitis C virus RNA renders the subject ineligible.
- •- Leptomeningeal disease and active brain metastases. Subjects who have had brain metastases resected or have received whole brain radiation therapy or stereotactic radiosurgery ending at least 2 weeks prior to registration are eligible if they meet all of the following criteria:
- •a) residual neurological symptoms grade = 2
- •b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and
- •c) follow-up brain imaging performed within 30 days of enrollment shows no progression or new lesions appearing
- •- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 days after the last dose of sotorasib or during treatment if planning to become pregnant
- •- Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additio
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