CTRI/2016/09/007293暂停2 期
A phase Ib/II, open-label, multicenter trial of cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic NSCLC with acquired resistance to prior EGFR TKI
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
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
入选标准
- •Patients must have received one and only one prior line of 1st generation (eg
- •erlotinib, gefitinib) or 2nd generation (afatinib) EGFR TKI for the treatment of
- •locally advanced or metastatic NSCLC
- •2. No prior chemotherapy is allowed, except in the following instances:
- •Patients, who switched from platinum-based chemotherapy to EGFR TKI during
- •first line treatment within 28 days since the start date of chemotherapy, will be
- •allowed to enter the study, in the absence of disease progression
- •3. Prior neoadjuvant/adjuvant cytotoxic chemotherapy is not allowed, unless the
- •relapse occurred more than 12 months
- •4.Molecular pre-screening assessment
- •cMET-amplification (GCN more than 6) by FISH determined by a Novartis-designated central
- •laboratory on a newly obtained tumor biopsy (preferred) or an archival tumor sample
- •obtained at or any time after the progression on prior 1st or 2nd generation EGFR TKI
- •5. EGFRT790M negative status assessed from a biopsy or an archival tumor sample
- •collected at or any time after the progression on prior 1st or 2nd generation EGFR TKI,
- •determined locally by either Roche Cobas or Qiagen therascreen test or by a Novartisdesignated
- •central laboratory
- •6. Presence of at least one measurable lesion according to RECIST v1.1. A previously
- •irradiated site lesion may only be counted as a target lesion if there is clear sign of
- •progression since the irradiation
- •More than 18 years of age at the time of informed consent.
- •Locally advanced or metastatic NSCLC (stage IIIB and is not a candidate for definitive
- •multimodality therapy or IV) other than predominantly squamous cell histology harboring
- •EGFR mutation known to be associated with EGFR TKI drug sensitivity (exon 19 deletion
- •Patients must meet the criteria for acquired resistance to EGFR TKI (either 1st generation
- •(eg erlotinib, gefitinib) or 2nd generation (eg, afatinib)) defined as
- •Documented clinical benefit (CR, PR, or SD (= 6 months) as per RECIST)
- •Demonstrated progression, while on continuous treatment, or within 30 days since the
- •date of last administration of EGFR TKI, per RECIST
- •Patients must have recovered from all toxicities related to prior anticancer therapies to
- •grade more 1 (CTCAE v 403). Patients with any grade of alopecia are allowed to enter the
- •Life expectancy more than 3 months
排除标准
- •Patients eligible for the Phase II of this study must not meet any of the following criteria
- •Patients with history of severe hypersensitivity reaction to platinum containing drugs,
- •pemetrexed or any known excipients of these drugs.
- •Prior treatment with any of the following agents
- •Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.
- •Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.
- •Platinum-based chemotherapy as first line treatment.
- •Thoracic radiotherapy to lung fields less than 4 weeks prior to study enrollment or patients who
- •have not recovered from radiotherapy related toxicities. For all other anatomic sites
- •including radiosurgery for brain metastasis, radiotherapy to thoracic vertebrae and ribs,
- •radiotherapy less than 2 weeks prior to starting study treatment or patients who have not
- •recovered from radiotherapy related toxicities
- •Presence or history of a malignant disease other than NSCLC that has been diagnosed
- •And or required therapy within the past 3 years. Exceptions to this exclusion include the
- •Following completely resected basal cell and squamous cell skin cancers, indolent
- •malignancies that currently do not require treatment, and completely resected carcinoma
- •in situ of any type
- •Presence of clinically significant ophthalmologic abnormalities that might increase the
- •risk of corneal epithelial injury, such as severe dry eye syndrome, keratoconjunctivitis
- •sicca, Sjogrens syndrome, and severe exposure keratopathy.
- •Bullous and exfoliative skin disorders at baseline of any grade
- •Presence or history of microangiopathic hemolytic anemia with thrombocytopenia.
- •Clinically significant, uncontrolled heart diseases and or recent cardiac event within 6
- •months prior to screening, such as
- •Unstable angina within 6 months prior to screening
- •Myocardial infarction within 6 months prior to screening
- •History of documented congestive heart failure New York Heart Association
- •functional classification 3 and 4
- •Ventricular arrhythmias
- •upraventricular and nodal arrhythmias not controlled with medication
- •Other cardiac arrhythmia not controlled with medication
- •QTCF more than 450 msec
研究者
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