WCLC 2025 - Posters & ePosters-P3.12.47 A Phase II Study of Sunvozertinib Combined With Chemotherapy in EGFR-TKIs Resistant EGFRm Advanced NSCLC Patients(WU-KONG36)

P3.12.47 A Phase II Study of Sunvozertinib Combined With Chemotherapy in EGFR-TKIs Resistant EGFRm Advanced NSCLC Patients(WU-KONG36)

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This Phase II study (WU-KONG36) conducted at West China Hospital evaluated the safety and efficacy of sunvozertinib combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR sensitizing mutations who were resistant to standard EGFR tyrosine kinase inhibitors (TKIs). Sunvozertinib is a highly selective EGFR TKI that previously showed promising activity as monotherapy. Preclinical studies demonstrated synergy when combined with chemotherapy.<br /><br />The study is an open-label, single-arm trial designed to enroll 40 patients, with two parts: Part A focused on safety and dose reduction; Part B is the dose-expansion phase. Initial dosing was sunvozertinib 200 mg daily plus platinum-based chemotherapy (cisplatin or carboplatin with pemetrexed), with a dose-reduction option to 150 mg if dose-limiting toxicities (DLTs) occurred.<br /><br />As of the data cut-off (April 29, 2025), 10 patients completed Part A. Median age was 53 years, 60% were female, all had ECOG performance status 1, and 90% had metastatic disease; all had prior third-generation EGFR TKI therapy. No DLTs or serious adverse events (SAEs) occurred, establishing the recommended combination dose (RCD) as sunvozertinib 200 mg daily with chemotherapy.<br /><br />Efficacy assessment showed an objective response rate (ORR) of 30% and a disease control rate (DCR) of 70% in these 10 patients. Treatment-emergent adverse events (TEAEs) were common but manageable, mostly hematologic toxicities (anemia, neutropenia, thrombocytopenia), diarrhea, and elevated liver enzymes. Grade 3 TEAEs occurred in 50% of patients, without treatment-related discontinuations or deaths.<br /><br />In conclusion, sunvozertinib combined with chemotherapy was well tolerated and demonstrated encouraging preliminary antitumor activity in EGFR mutant NSCLC patients resistant to prior EGFR TKIs, supporting further clinical evaluation. The trial is registered as NCT06195189.

Asset Subtitle

Feifei Na

Meta Tag

Speaker Feifei Na

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

Sunvozertinib

Non-small cell lung cancer

NSCLC

EGFR mutations

Tyrosine kinase inhibitors

Chemotherapy

Phase II clinical trial

Safety and efficacy

Objective response rate

Treatment-emergent adverse events