EUCTR2019-003806-28-PL招募中1 期
Phase 1b/2a safety and tolerability study of bemcentinib withpembrolizumab/carboplatin/pemetrexed in subjects with untreatedadvanced or metastatic non-squamous non-small cell lung cancer(NSCLC) without/with a STK11 mutation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
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
- •1. The subject (or legally acceptable representative, if applicable) must provide written
- •informed consent for the study prior to any screening procedures.
- •2. Be = 18 years of age on the day of signing the informed consent.
- •3. Have a histologically- or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc)
- •or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to
- •curative therapy, irrespective of PD-L1 status and without actionable mutations
- •(Phase 1b).
- •4. Have a histologically- or cytologically confirmed diagnosis of advanced (Stage
- •IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11
- •m, not amenable to curative therapy, irrespective of PD-L1 status and without
- •actionable mutations (Phase 2a).
- •5. Participants who received prior neo-adjuvant or adjuvant/consolidation treatment
- •(radiotherapy, chemotherapy, immunotherapy) or chemoradiotherapy with curative
- •intent for non-metastatic disease must have experienced a treatment-free interval of
- •at least 6 months since the last dose of chemotherapy, immunotherapy and/or
- •radiotherapy before enrollment
- •6. Have measurable disease per RECIST 1.1 as assessed by the investigator. Lesions
- •situated in a previously irradiated area are considered measurable if progression has
- •been demonstrated in such lesions.
- •The exhaustive list of the inclusion criteria is available in the protocol.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1. Has received any prior chemotherapy or biological therapy for advanced
- •(Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC.
- •2. Has any actionable mutation that is considered targetable with first-line treatment.
- •3. Has a known history of prior malignancy except if the subject has undergone
- •potentially curative therapy with no evidence of disease recurrence for 3 years since
- •initiation of that therapy.
- •4. Has known active central nervous system (CNS) metastases and/or carcinomatous
- •meningitis. Subjects with previously treated brain metastases may participate,
- •provided they are radiologically stable, i.e. without evidence of progression for at least
- •2 weeks and have no evidence of new or enlarging brain metastases and are off steroids
- •7 days prior to dosing with study medication. Stable brain metastases by this definition
- •should be established prior to the first dose of study medication. Subjects with
- •asymptomatic brain metastases (i.e. no neurological symptoms, no requirements for
- •corticosteroids, and no lesion >1.5cm) may participate but will require regular imaging
- •of the brain as a site of disease. Subjects who have
- •experienced an acute neurological event (e.g. intracranial or
- •subarachnoid haemorrhage, stroke, intracranial trauma) within 6
- •months prior to study enrolment will be excluded.
- •5. History of the following cardiac conditions:
- •a. Congestive cardiac failure of >Grade II severity according to the New
- •York Heart Association (NYHA) or
- •resistant or inadequately treated heart failure.
- •b. Ischemic cardiac event including myocardial infarction prior to first dose or hospitalization for
- •unstable angina within 3 months prior to first dose.
- •c. Abnormal left ventricular ejection fraction on echocardiography or multigated
- •acquisition scan (MUGA) (less than the lower limit of normal for a subject of
- •that age at the treating institution or <45%, whichever is lower), or history of cardiomyopathy or left ventricular hypertrophy.
- •d. Uncontrolled cardiac disease, including unstable angina, uncontrolled
- •hypertension (i.e. sustained systolic blood pressure (BP) >160 mmHg or
- •diastolic BP >90 mmHg), or need to change medication due to lack of disease
- •control within 12 weeks prior to the provision of consent.
- •e. History or presence of sustained bradycardia (=55 bpm) or history of
- •symptomatic bradycardia, left bundle branch block, cardiac pacemaker or
- •significant arrhythmias or any conduction disorder within 6 months prior
- •to dosing as defined by the need for treatment.
- •f. Family history of long QTc syndrome or ventricular arrhythmias; personal
- •history of long QTc syndrome or previous drug induced QTc prolongation of at
- •least Grade 3 (QTc >500ms).
- •g. Presence of any other risk factors that increase the risk of QTc prolongation,
- •specifically, hypokalemia or hypomagnesemia (if corrected the subject may be
- •enrolled) or inadequately treated hypothyroidism (defined as thyroid
- •stimulating hormone (TSH) below the expected range).
- •h. Current treatment with any agent known to cause QT prolongation and have a
- •risk for Torsades de pointes (TdP), which cannot be discontinued at least 5 and
- •½ half-lives or 2 weeks prior to the first dose of study treatment, with the
- •exception of antiemetics (e.g. ondansetron) which may be required. Please see
- •https://crediblemeds.org for a list of medications with known TdP
- •risk that need to be excluded.
- •The exhaustive list of the exclusion criteria is available in
研究者
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