A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

Summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Timeline

Start

2023-06-26

Primary completion

2024-07-11

Completion

2026-09-30

Publications

• Fang W, Wu L, Meng X, Yao Y, Zuo W, Yao W, Xie Y, Zhang Y, Cui J, Zhang Y, Li X, Zhuang W, Fang J, Wang Q, Jiang W, Li K, Bai Y, Luo Y, Ma F, Yu Y, Zheng W, Liu Z, Yang B, Ma R, Fang Y, Yang R, Jiang L, Hu J, Yang J, Diao Y, Jin X, Ge J, Yang Y, Zhang L. Sacituzumab Tirumotecan in EGFR-TKI-Resistant, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026 Jan 1;394(1):13-26. doi: 10.1056/NEJMoa2512071. Epub 2025 Oct 19.

Drugs

Indications