JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study

This is a Phase II study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212 in combination with JS111 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who have progressed after prior EGFR-TKI therapy. The study consists of two parts: a dose-escalation phase followed by an expansion phase. Approximately 30 participants will be enrolled. The dose-escalation phase will explore the safety and tolerability of escalating doses of JS212 in combination with a fixed dose of JS111, using a Bayesian optimal interval (BOIN) design. Based on safety and tolerability data, a recommended Phase III dose (RP3D) will be determined. The expansion phase will further evaluate safety and preliminary anti-tumor activity at the selected dose level.

NCT Number	NCT07518160
Lead Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Conditions	Locally Advanced, Metastatic, or Recurrent Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations
Enrollment	35 participants
Start Date	2026-04-21
Primary Completion	2028-04-23 (estimated)
Study Completion	2029-04-23 (estimated)
Updated on ClinicalTrials.gov	2026-07-07