EUCTR2011-000634-11-GR进行中（未招募）不适用
A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (NSCLC Stage IIIBwet-IV).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent.
- •2. 18 years old or older.
- •3. Histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage
- •IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC with a
- •positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene (performed
- •in a CLIA-certified laboratory or equivalent). View page page 27 of the protocol for further information.
- •4. Documented tumor progression (based on radiological imaging) after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC.
- •a. Erlotinib maintenance therapy following first-line treatment with any approved
- •platinum-containing chemotherapy for advanced stage/metastatic NSCLC is allowed.
- •b. Pemetrexed maintenance therapy is only allowed following a first-line treatment
- •with cisplatin or carboplatin and pemetrexed for advanced stage/metastatic
- •c. Patients who have received any treatment (e.g., erlotinib, chemotherapy, or
- •Investigational Agents) in a second-line setting are not allowed.
- •5. Measurable disease, i.e., presenting with at least one measurable tumor lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •6. Performance status score of 0 or 1 according to the Eastern Cooperative Oncology
- •Group (ECOG) scale.
- •7. Able to swallow and retain orally administered medication and does not have any
- •clinically significant gastrointestinal abnormalities that may alter absorption such as expectancy of at least three months in the opinion of the investigator.
- •8. Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception, as defined in the protocol, during the study and for at least four weeks following the last dose of study medication. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in the protocol from the time of randomization to study medication until at least four weeks after the last dose of study treatment. However, the Sponsor advises that contraception be used for a total of 16 weeks following the last dose (based on the lifecycle of sperm). Investigators should reference the product label for docetaxel for additional clarification.
- •9. Adequate baseline organ function as defined in Table 2.
- •10. French subjects: In France, a subject will be eligible for inclusion in this study only
- •if either affiliated to or a beneficiary of a social security category.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •1. History of another malignancy. Exception: (a) history of curatively treated
- •malignancy different from NSCLC with a disease-free period of = 3 years, (b)
- •history of completely resected non-melanoma skin cancer, (c) successfully treated in
- •situ carcinoma, (d) CLL in stable remission (Rai Stage 0) with no therapy required,
- •(e) indolent prostate cancer requiring no or only anti-hormonal therapy with
- •histologically confirmed tumor lesions that can be clearly differentiated from
- •NSCLC target and non-target lesions.
- •2. Any serious and/or unstable pre-existing medical disorder (aside from malignancy
- •exception above), psychiatric disorder, or other conditions that could interfere with
- •subject’s safety, obtaining informed consent or compliance to the study procedures,
- •in the opinion of the Investigator.
- •3. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to
- •drugs chemically related to study drugs, excipients, dimethyl sulfoxide (DMSO), or
- •to polysorbate 80.
- •4. Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of
- •a combination regimen.
- •5. Anti-cancer therapy (including chemotherapy and radiation therapy) within the last
- •three weeks.
- •6. Current use of a prohibited medication (see Section 6.2 titled Prohibited Medications and Non-Drug Therapies). Use of anticoagulants such as warfarin is permitted (see Section 6.1 title Permitted Mediations of the protocol), however INR must be monitored in
- •accordance with local institutional practice.
- •7. History or current evidence / risk of retinal vein occlusion (RVO) or central serous
- •retinopathy (CSR):
- •- History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled
- •glaucoma or ocular hypertension, uncontrolled systemic disease such as
- •hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability
- •syndromes).
- •- Visible retinal pathology as assessed by ophthalmic exam that is considered a risk
- •factor for RVO or CSR such as: Evidence of new optic disc cupping; Evidence of
- •new visual field defects; Intraocular pressure > 21 mm Hg as measured by
- •tonography.
- •8. Any tumor manifestation in the CNS.
- •9. History or evidence of cardiovascular risk including any of the following:
- •a. QTcB = 480 msec.
- •b. History or evidence of current clinically significant uncontrolled arrhythmias.
- •Exception: Subjects with controlled atrial fibrillation for >30 days prior to
- •randomization are eligible.
- •c. History of acute coronary syndromes (including myocardial infarction and
- •unstable angina), coronary angioplasty, or stenting within 6 months prior to
- •randomization.
- •d. History or evidence of current = Class II congestive heart failure as defined by
- •New York Heart Association (Appendix 4).
- •10. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or
- •Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV
- •and HCV infection which will be allowed).
- •11. French subjects: the French subject has participated in any study using an
- •investigational drug during the previous 30 days.
研究者
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