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 opti

Trial Details

NCT ID
NCT07518160
Phase
PHASE2
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • JS212 for Injection＋JS111 capsules (AP-L1898)
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Participants must meet all of the following criteria to be eligible for this study:
  • Age between 18 and 75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of sex;
  • Histologically or cytologically confirmed recurrent or metastatic non-squamous NSCLC that is unresectable and not amenable to curative chemoradioth…
  • Confirmed EGFR-sensitizing mutation, including:

For full eligibility, visit ClinicalTrials.gov.

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