Chemotherapy in KRAS mutated chemotherapy naive non-small cell lung cancer patients: a phase III study comparing cisplatin-pemetrexed with carboplatin-paclitaxel-bevacizumab: NVALT 22

Stichting NVALT studies0 个研究点目标入组 240 人开始时间: 2016年3月21日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1.Histologically or cytologically confirmed (non-squamous) NSCLC incurable locally advanced or metastatic (stage IIIB and stage IV) disease.
•2.Documented KRAS mutation
•3.Chemotherapy-naive NSCLC patients. Previous anti-PD(L1) therapy for advanced disease is allowed.
•4.At least one unidimensionally measurable lesion meeting RECIST1.1.
•5.ECOG PS 0-2
•6.Age > 18 years
•7.Adequate organ function, including:
•a.Adequate bone marrow reserve: ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
•b.Hepatic: bilirubin <=1.5 x ULN, AP, ALT, AST <= 3.0 x ULN
•AP, ALT, and AST <=5 xULN is acceptable if the liver has tumor involvement
•c.Renal: calculated creatinine clearance >= 60 ml/min based on the Cockroft-Gault formula.
•d.Urine protein (dip-stick) < 2 +; when >=2 +: 24 hours urine protein <=1 gr.
•8.Signed informed consent
•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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Pregnant or lactating women
•2.Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 150 mmHg and/or diastolic > 100 mmHg)
•3.History of hemoptysis = grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
•4.Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery)
•5.Patients with evidence or history of bleeding diathesis
•6.Non-healing wound or ulcer
•7.Surgical intervention within 28 days
•8.History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
•9.Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection
•10.Documented symptomatic brain metastases unless the patient has completed local therapy for central nervous system metastases.
•11.Concomitant treatment with any other experimental drug under investigation.
•12.Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
•13.Previous or active concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study
•14.History of HIV infection or chronic hepatitis B or C
•15.Active clinically serious infection

发起方

Stichting NVALT studies