本研究的目的是比较 TAK-788 作为第一线治疗与含铂化疗在肿瘤带有表皮生长因子受体（EGFR）exon 20 insertion 突变的局部晚期或转移性非小细胞肺癌（NSCLC）参与者中的疗效。参与者将被随机分配至两个治疗组之一——TAK-788 组或含铂化疗组。参与者将接受 TA

适应症：Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

入组条件

Male or female adult patients (aged 18 years or older)
Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC
Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors \[TKIs\] (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 exon 20 insertion mutation
At least 1 measurable lesion per RECIST Version 1.1
Life expectancy ≥3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Adequate organ and hematologic function as defined by blood transfusions with a recommended \>/ 14 day washout period.

Received prior systemic treatment for locally advanced or metastatic disease, including local administration, such as intra-pleural injection of anticancer medication with the exception noted 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
Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before first dose of TAK-788
Have been diagnosed with another primary malignancy other than NSCLC
Have current spinal cord compression or leptomeningeal disease
Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin
Taking medication(s) known to be associated with the development of torsades de pointes.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。

TAK-788 作为第一线治疗对比含铂化疗用于带 EGFR Exon 20 Insertion 突变的非小细胞肺癌（NSCLC）