[Translation] Phase II clinical study on the safety and efficacy of BEBT-109 combined with chemotherapy as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation
主要目的:
评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌的安全性。
次要目的:
评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌的有效性;
评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌患者中药代动力学特征。
[Translation] Primary objective:
To evaluate the safety of BEBT-109 combined with pemetrexed and carboplatin or cisplatin as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.
Secondary objective:
To evaluate the efficacy of BEBT-109 combined with pemetrexed and carboplatin or cisplatin as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations;
To evaluate the pharmacokinetic characteristics of BEBT-109 combined with pemetrexed and carboplatin or cisplatin as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.