CTRI/2017/12/010781Other2/3 期
A Phase II/III Pivotal, Open-label, Randomized, 3 Arm Study to Assess the Efficacy of LNP3794 Monotherapy or in Combination with Docetaxel, Compared with Docetaxel Alone, in Patients with RAS Mutation Positive Locally Advanced and Metastatic Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 2/3 期
- 状态
- Other
- 入组人数
- 141
- 试验地点
- 39
- 主要终点
- To evaluate the progression free survival (PFS) in the treatment arms in the target population.
研究概览
简要总结
This is a Phase II/III, pivotal, 3 arm, randomized, multi-center, open label, parallel group study in NSCLC patients who are positive for RAS mutations (KRAS, NRAS or HRAS). The study will evaluate the efficacy, safety, tolerability, PK and PD of LNP3794 administered alone or in combination with docetaxel compared to docetaxel alone.
Due to poor accrual rate and because of negligible incidence of RAS mutation positive NSCLC patients encountered in the study Lupin decided to terminate the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender (≥ 18 years) with locally advanced or metastatic NSCLC that has progressed after standard treatment, which must have included platinum-doublet chemotherapy and/or a programmed cell death protein 1 [PD 1]/programmed cell death protein ligand 1 [PD-L1] inhibitors 2.Patients with a histologically or cytologically confirmed diagnosis of locally advanced or metastatic Stage IIIB or Stage IV NSCLC 3.Confirmed activating RAS mutational status based on circulating tumor deoxyribose nucleic acid (ctDNA) as determined by the central testing laboratory 4.Failure of anti-cancer therapy (as provided in inclusion criteria no.
- •based on a history of radiological documentation of disease progression in advanced disease or subsequent relapse of the disease 5.Patients with measurable disease, i.e., presenting with at least one measurable tumor lesion as per RECIST v1.1 6.Patients with an ECOG performance status score of ≤ 2 7.Patients must be able to swallow and retain orally administered medication and not have any clinically significant gastrointestinal abnormalities that may alter absorption 8.Patients must have clinical laboratory values that meet the following criteria: a.Absolute neutrophil count ≥ 1.5 × 109/L b.Platelets ≥ 100 × 109/L c.Hemoglobin ≥ 8 g/dL d.Liver function tests: i.Serum bilirubin ≤ 1.2 x upper limit of normal (ULN) ii.AST and ALT ≤ 3 x ULN without liver metastases or ≤ 5 × ULN if the patient has documented liver metastases iii.International normalized ratio (INR) < 1.3 if the patient is not on anticoagulants or < 3 if the patient is on anticoagulants e.Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate > 40 mL/min/1.73 m2 f.Serum amylase ≤ 1.5 × ULN g.Serum lipase ≤ 1.5 × ULN 9.Patients must have adequate life expectancy in the opinion of the Investigator 10.Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute Common terminology criteria for adverse events version 4.03 (NCI-CTCAE v4.03) 11.Women of childbearing potential must have a negative serum pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry through at least 3 months after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence) 12.A female patient of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, follicle stimulating hormone (FSH) level > 40 mIU/mL at Screening, or have had surgical bilateral oophorectomy, hysterectomy, or tubal ligation > 6 weeks prior to Screening; in the case of oophorectomy alone, reproductive status will be confirmed by hormone level assessment 13.A male patient must agree to use adequate contraception from study entry through at least 3 months after the last dose of study medication 14.Patients must be willing to undergo and able to tolerate frequent magnetic resonance imaging (MRI) or computed tomography (CT) assessments during the study 15.Patients must be able to understand and be willing to complete symptom assessments using a PRO instrument 16.Patients must be able to understand and be willing to voluntary provide signed and dated written informed consent 17.Patients willing and able to comply with the requirements of the protocol.
排除标准
- •1.Patients with central nervous system metastases as confirmed by CT/MRI of brain 2.Patients with a history of another primary malignancy, with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
- •A patient who has had no evidence of disease from another primary cancer for 5 or more years is allowed to participate in the study 3.Patients with any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, seizure disorder, or other conditions that could interfere with the patient’s safety, providing informed consent or compliance to the study procedures, in the opinion of the Investigator 4.Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to LNP3794, docetaxel or its excipients 5.Patients with a history of treatment with MEK inhibitors (such as selumetinib, trametinib, and sorafenib), BRAF inhibitors (such as dabrafenib, vemurafenib) or docetaxel as monotherapy or as part of a combination regimen or study regimen (Note: prior treatment with paclitaxel is acceptable) 6.Anti-cancer therapy (including chemotherapy and radiation therapy) within the last 3 weeks prior to randomization or limited field of radiation for palliation within 7 days of the first dose of study medication 7.Patients who have any contraindication for therapy with docetaxel 8.Patients who have a history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy; for example predisposing factors of RVO or central serous retinopathy include uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes 10.Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator, could affect the patient’s participation in the study 11.Patients who have liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis, or chronic persistent hepatitis.
结局指标
主要结局
To evaluate the progression free survival (PFS) in the treatment arms in the target population.
时间窗: 12 months
次要结局
- •To examine measures of efficacy, including overall survival (OS), objective response rate (ORR), duration of response (DOR), and best overall response (BOR) in the target population.(To evaluate measures of safety and tolerability for patients in the study.)
研究者
研究点 (39)
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