drugset / Trial / NCT07181499

Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

NCT07181499

Phase 2 Recruiting 28 enrolled Betta Pharmaceuticals Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib/sintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of "pemetrexed + carboplatin followed by befotertinib" for patients resistant to third-generation TKIs.

Timeline

Start
2025-09
Primary completion
2028-11
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Befotertinib Small molecule 75 mg Oral
Subject Befotertinib Small molecule 100 mg Oral
Subject Carboplatin Small molecule 5 unknown
Subject Pemetrexed Small molecule 500 mg/m2