JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
JS212 for Injection＋JS111 capsules (AP-L1898)
DrugJS212 for Injection: JS212 injection was given every 21 days JS111 capsules (AP-L1898) : JS111 160 mg orally once daily
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: JS212 for Injection + JS111 capsules (AP-L1898)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Objective response rate (ORR), assessed per RECIST v1.1.
Time frame
up to 3 years2
RP3D
Determination of the recommended Phase III dose (RP3D) for JS212 + JS111.
Time frame
up to 3 years3
Safety (AE)
Incidence and severity of adverse events (AEs), and abnormal laboratory or clinical findings.
Time frame
up to 6 yearsSecondary outcomes
1
PFS
Progression-free survival (PFS), assessed by investigators (RECIST v1.1).
Time frame
up to 6 years2
DoR
Duration of response (DoR), assessed by BICR and investigators.
Time frame
up to 6 years3
DCR
Disease control rate (DCR), assessed by BICR and investigators.
Time frame
up to 6 years4
OS
overall survival (OS)
Time frame
up to 6 yearsSponsors and contacts
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Source ClinicalTrials.gov