JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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 chemoradiotherapy;
At least one measurable lesion per RECIST v1.1;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Disqualifiers
Within: 4 weeks or 5 half-lives (whichever is shorter) prior to first dose: chemotherapy or similar therapies;7 days: small molecule targeted therapy; 2 weeks: localized radiotherapy (e.g., palliative radiation for bone metastases);
Use of strong CYP3A inhibitors or inducers within 14 days prior to first dose or requirement for continued use during study;
Current use or requirement for use of medications known to prolong QT interval or cause torsades de pointes;
Receipt of any investigational drug within 4 weeks or 5 half-lives prior to first dose (whichever is shorter);
Trial design
Treatments tested in this trial
- JS212 for Injection＋JS111 capsules (AP-L1898)
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov