JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study (NCT07518160) | Clinical Trial Compass
Not Yet RecruitingPhase 2
JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study
China35 participantsStarted 2026-03-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Confirmed EGFR-sensitizing mutation, including:
. Prior treatment with:
. At least one measurable lesion per RECIST v1.1;
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
. Estimated life expectancy of ≥12 weeks;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate organ function meeting the following criteria (Note: No blood transfusion or hematopoietic growth factors are allowed within 14 days prior to screening assessments):
Exclusion criteria
. Disease-related conditions:
. Prior/concomitant treatments:
. 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);
. Participation in another clinical trial, unless it is: Observational (non-interventional), or The participant is in the follow-up phase of an interventional study;
. Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to first dose;