Locally Advanced Metastatic Or Recurrent Non Small Cell Lung Cancer Nsclc Harboring Epidermal Growth Factor Receptor Egfr Mutations

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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 35
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Junshi Bioscience Co., Ltd.Updated: Apr 8, 2026Locations: 2
Eligibility criteria

Age between 18 and 75 years (inclusive) at the time of signing the informed cons... [+13]

Within: 4 weeks or 5 half-lives (whichever is shorter) prior to first dose: chem... [+20]