EUCTR2011-001161-41-ES进行中（未招募）1 期
A Phase II study of the BRAF inhibitor dabrafenib as a single agent and incombination with the MEK inhibitor trametinib in subjects with BRAF V600E mutation positive metastatic (stage IV) non-small cell lung cancer.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- •Subjects eligible for enrolment in the study and previously enrolled
- •subjects crossing over from monotherapy to combination therapy must
- •meet all of the following criteria:
- •1. Signed written informed consent;
- •2. Histologically- or cytologically-confirmed diagnosis of NSCLC stage IV
- •(according to AJCC Staging 7th Edition);
- •3. Documented tumor progression (based on radiological imaging) after
- •receiving at least one prior approved platinum-based chemotherapy
- •regimen for advanced stage/metastatic NSCLC. An altérnate chemotherapeutic agent/regimen is an acceptable substitute in the
- •event that the subject was intolerant to, or ineligible to receive platinum
- •based chemotherapy. Subjects enrolled in Cohort B cannot have more
- •than 3 prior systemic treatments for advanced stage/metastatic NSCLC
- •(neoadjuvant and adjuvant therapies are not counted in number of prior
- •regimens and maintenance therapy is not counted as a separate
- •4. Measurable disease according to RECIST v1.1 [Eisenhauer, 2009].
- •Refer to Section 7.2.3.1 for the definition of a measurable lesion;
- •5. Male or female >=18 years of age;
- •6. Anticipated life expectancy of at least 3 months;
- •7. Presence of a BRAF V600E mutation in lung cancer tissue. Mutation
- •must be locally confirmed in a CLIA-certified laboratory (or equivalent).
- •An adequate amount of umor tissue (archived tumor tissue, or fresh
- •biopsy if archived tissue is not available) must be available at the time of
- •enrolment for central validation of BRAF mutation see Section 7.1.1 for
- •testing details and requirements regarding central confirmation);
- •8. Able to swallow and retain oral medication;
- •9. Women of childbearing potential must have a negative serum
- •pregnancy test within 14 days before the first dose of study treatment
- •and agree to use effective contraception, as defined in Section 7.4,
- •during the study;
- •NOTE: Oral contraceptives are not reliable due to potential drug-drug
- •interaction with dabrafenib
- •10. Eastern Cooperative Oncology Group (ECOG) Performance Status of
- •0-2 [Oken, 1982];
- •11. Must have adequate baseline organ function as definedin Table 1:
- •Hematologica
- •ANC >= 1.5 × 109/L
- •Hemoglobin >= 9 g/dL
- •Platelet count >= 100 x 109/L
- •PT/INRb and PTT = 1.3 x ULN
- •Total bilirubin = 1.5 x ULN
- •AST and ALT = 2.5 x ULN
- •Renal (at least one of the following):
- •Serum creatininec = 1.5 mg/dL
- •Creatinine clearancec >= 50 mL/min
- •Left Ventricular Ejection fraction (LVEF)d >= LLN by ECHO
- •12. 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
- •13. Previously tested for presence of EGFR and ALK mutations in lung
- •cancer tissue confirmed in a CLIA-certified laboratory (or equivalent).
- •Subjects with EGFR or ALK mutation are eligible if they have previously
- 另有 7 项未显示
排除标准
- •Subjects eligible for enrolment in the study and previously enrolled subjects crossing over from monotherapy to combination therapy must not meet any of the following criteria:
- •1.Previous treatment with a BRAF inhibitor (including but not limited to dabrafenib, vemurafenib, LGX818, and XL281/BMS-908662) or MEK inhibitor (including but not limited to trametinib, AZD6244, and RDEA119) prior to start of study treatment (Note: Prior treatment with dabrafenib is allowed for crossover subjects in Cohort A);
- •2.Anti-Cancer therapy including chemotherapy, radiation-therapy, immunotherapy, biologic therapy or major surgery within 14 days prior to start of study treatment (Note: Dabrafenib monotherapy within 14 days prior to starting combination therapy is allowed for crossover subjects in Cohort A);
- •3.Use of any investigational anti-cancer drug within 14 days or 5-halflives (minimum 14 days), prior to start of study medication (Note: Dabrafenib monotherapy within 14 days prior to starting combination therapy is allowed for crossover subjects in Cohort A);
- •4.Current use of a prohibited medication or expected to require any of thesemedications during treatment with study treatment (See Section 6.2);
- •5.Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) [NCI, 2009] Grade 2 or higher from previous anti-cancer therapy, except alopecia;
- •6.Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GlaxoSmithKline (GSK) medical monitor for guidance to enrol the subject;
- •7.Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. Subjects with laboratory evidence of cleared HBV and HCV infection may be enrolled;
- •8.History of another malignancy < 3 years prior to starting study treatment or any malignancy with confirmed activating RAS-mutation; Exceptions: subjects with any of the following malignancies within 3 years (does not include malignancies with confirmed activating RASmutation) are eligible:(a) a history of completely resected skin cancer; (b) successfully treated in situ carcinoma,(c) chronic lymphocytic lymphoma (CLL) in stable remission, or (d) indolent prostate cancer (definition: clinical stage T1 or T2a, Gleason score <=6, and prostate specific antigen [PSA] < 10 ng/mL) requiring no or only anti-hormonal therapy with histologically confirmed tumour lesions that can be clearly differentiated from lung cancer target and non-target lesions are eligible
- •9.Subjects with brain metastases are excluded if their brain metastases are:
- •Symptomatic OR
- •Treated (surgery, radiation therapy) but not clinically and radiographically stable 3 weeks after local therapy(as assessed by contrast enhanced magnetic resonance imaging [MRI] or computed tomography [CT]), OR
- •Asymptomatic and untreated but >1 cm in the longest dimension
- •10.A history or evidence of cardiovascular risk including any of the following:
- •Corrected QT (QTc) interval >=480 msecs
- •History of acute coronary syndromes (including myocardial infarction or unstable angina) within 6 months prior to first dose of study treatment
- •Coronary angioplasty, or stenting within the past 24 weeks;
- •A history or evidence of current Class II, III, or IV heart failure as defined by
研究者
相似试验
进行中（未招募）
1 期
A study to test a new drug for treating non-small cell lung cancerAdvanced non-small cell lung cancer and BRAF mutationsMedDRA version: 18.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001161-41-ITGlaxoSmithKline Research and Development Limited100
进行中（未招募）
1 期
A study to test a new drug for treating non-small cell lung cancerEUCTR2011-001161-41-GBovartis Pharma Services AG166
进行中（未招募）
1 期
A study to test a new drug for treating non-small cell lung cancerEUCTR2011-001161-41-NLovartis Pharma Services AG166
进行中（未招募）
1 期
A study to test a new drug for treating non-small cell lung cancerEUCTR2011-001161-41-DEovartis Pharma Services AG100
进行中（未招募）
1 期
Encorafenib in combination with Binimetinib in Patients with BRAFV600E-mutant metastatic Lung CancerEUCTR2019-004621-24-FRIFCT105