CTRI/2020/07/026825进行中（未招募）4 期
Single arm study to evaluate the safety of Dacomitinib for the first-line treatment of participants in India with metastatic non-small cell lung cancer with epidermalgrowth factor receptor (EGFR)-activating mutations
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
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
- •(1)Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test.
- •(2)No prior treatment with systemic therapy and EGFR/Other TKIs for metastatic NSCLC.
- •(3)Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible.
- •(4)Age ââ?°Â¥18 years.
- •(5)ECOG PS of 0-2.
- •(6)Adequate. hematologic, renal, liver function.
- •(7)Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade <1 except for AEs that in the investigators judgment do not constitute a safety risk for the participant.
- •(8)Serum or urine pregnancy test (for females of childbearing potential) negative at Screening. Contraceptive use should be consistent with the approved India local product document for Dacomitinib.
排除标准
- •(1)Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer
- •(2)Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation
- •(3)Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation ( <10 fractions) must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry. Prior irradiation to >25% of the bone marrow.
- •(4)Major surgery within 4 weeks prior to first dose of Dacomitinib. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.
- •(5)Known prior or suspected severe hypersensitivity to Dacomitinib or any component of its formulation
- •(6)History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
- •(7)Other severe acute or chronic medical or psychiatric condition, that may interfere with the interpretation of study results and, would make the participant inappropriate for entry into this study.
- •(8)Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of Dacomitinib.
- •(9)Breastfeeding female participants
- •(10)Participation in other studies involving investigational drug(s) (Phases 1 - 4) within 2 weeks before the current study begins and/or during study participation.
研究者
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