本研究的目的是比較 TAK-788 作為第一線治療與含鉑化療在腫瘤帶有表皮生長因子受體（EGFR）exon 20 insertion 突變的局部晚期或轉移性非小細胞肺癌（NSCLC）參與者中的療效。參與者將被隨機分配至兩個治療組之一——TAK-788 組或含鉑化療組。參與者將接受 TA

適應症：Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

收案條件

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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。

TAK-788 作為第一線治療對比含鉑化療用於帶 EGFR Exon 20 Insertion 突變的非小細胞肺癌（NSCLC）