NL-OMON54828已完成3 期
A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations - TAK-788-3001
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
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
- 年龄范围
- 18 至 64（—）
入选标准
- •Male or female adult patients (aged 18 years or older, or as defined per
- •local regulations).
- •Histologically or cytologically confirmed nonsquamous cell locally advanced
- •not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
- •A documented EGFR in-frame exon 20 insertion mutation sometimes referred to
- •as duplication (including A763_Y764insFQEA, V769_D770insASV [ASV duplication],
- •D770_N771insNPG, D770_N771insSVD [SVD duplication], H773_V774insNPH [NPH
- •duplication], or any other in-frame exon 20 insertion mutation) assessed by a
- •Clinical Laboratory Improvements Amendment-certified (United States [US] sites)
- •or an accredited (outside of the US) local laboratory. The local molecular
- •testing reports may be required by the sponsor to confirm the exon 20 insertion
- •mutation status. The EGFR exon 20 insertion mutation can be either alone or in
- •combination with other EGFR or HER2 mutations except EGFR mutations for which
- •there are approved EGFR tyrosine kinase inhibitors (ie, exon 19 del, L858R,
- •T790M, L861Q, G719X, or S768I, where X is any other amino acid).
- •Adequate tumor tissue available, either from primary or metastatic sites, for
- •central laboratory confirmation of EGFR in-frame exon 20 insertion mutation.
- •Note: confirmation of central test positivity is not required before
- •randomization.
- •At least 1 measurable lesion per RECIST version 1.1. Previously irradiated
- •lesions may not be used for target lesions, unless there is unambiguous
- •radiological progression after radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •Adequate organ and hematologic function, as determined by the following:
- •-- Blood transfusions are permitted with a recommended >=14-day washout
- •period before blood samples are obtained for Cycle 1 Day 1 laboratory
- •evaluations. This washout period may be shortened if deemed medically necessary
- •by the principal investigator (but it must not
- •be <7 days).
- •- Alanine aminotransferase/aspartate aminotransferase <=2.5 times the upper
- •limit of the normal range (ULN; <=5 times the ULN is acceptable if liver
- •metastases are present).
- •- Total serum bilirubin <=1.5 times the ULN (<=3.0 times the ULN for patients
- •with Gilbert syndrome or if liver metastases are present).
- •- Estimated creatinine clearance >=45 mL/min (calculated by using the
- •Cockcroft-Gault equation).
- •- Serum albumin >=2 g/dL.
- •- Serum lipase <=1.5 times the ULN.
- •- Serum amylase <=1.5 times the ULN unless the increased serum amylase is due to
- •salivary isoenzymes.
- •- Absolute neutrophil count >=1500/µL.
- •- Platelets >=100,000/µL.
- •- Hemoglobin >=9 g/dL.
- •- Serum electrolytes within normal ranges (ie, calcium, magnesium,
- •potassium, and sodium) based on local laboratory testing.
排除标准
- •Received prior systemic treatment for locally advanced or metastatic disease
- •(with the exception below):
- •Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or
- •combined modality chemotherapy/radiation for locally advanced disease is
- •allowed if completed >6 months before the development of metastatic disease.
- •Received radiotherapy <=14 days before randomization or has not recovered from
- •radiotherapy-related toxicities. Palliative radiation administered outside the
- •chest and brain, stereotactic radiosurgery, and stereotactic body radiotherapy
- •are allowed up to 7 days before randomization.
- •Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate
- •or strong CYP3A inducer within 10 days before randomization.
- •Had major surgery within 28 days before randomization. Minor surgical
- •procedures such as catheter placement or minimally invasive biopsies are
- •Have been diagnosed with another primary malignancy other than NSCLC, except
- •for adequately treated nonmelanoma skin cancer or cervical cancer in situ;
- •definitively treated nonmetastatic prostate cancer; or patients with another
- •primary malignancy who are definitively relapse-free with at least 3 years
- •elapsed since the diagnosis of the other primary malignancy.
- •Have known active brain metastases (have either previously untreated
- •intracranial central nervous system [CNS] metastases or previously treated
- •intracranial CNS metastases with radiologically documented new or progressing
- •CNS lesions). Brain metastases are allowed if they have been treated with
- •surgery and/or radiation and have been stable without requiring corticosteroids
- •to control symptoms within 7 days before randomization and have no evidence of
- •new or enlarging brain metastases.
- •Have current spinal cord compression (symptomatic or asymptomatic and
- •detected by radiographic imaging) or leptomeningeal disease (symptomatic or
- •asymptomatic).
- •Currently being treated with medications known to be associated with the
- •development of torsades de pointes.
- •Currently have or have had a history of interstitial lung disease, radiation
- •pneumonitis that required steroid treatment, or drug-related pneumonitis.
- •Have an ongoing or active infection including, but not limited to, the
- •requirement for intravenous antibiotics, or a known history of HIV. Testing for
- •HIV is not required in the absence of history.
- •Note: Hepatitis B surface antigen-positive patients are allowed to enroll if
- •hepatitis B virus DNA is below 1000 copies/mL in the plasma. Patients who are
- •positive for anti-hepatitis C virus antibody can be enrolled but must not have
- •detectable hepatitis C virus RNA in the plasma.
- •Received a live vaccine within 4 weeks before randomization per SmPCs for
- •pemetrexed, cisplatin,and carboplatin.
研究者
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