JS212 in Combination With JS111 as First-Line Treatment in EGFR-Mutant Advanced NSCLC (NCT07714304) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
JS212 in Combination With JS111 as First-Line Treatment in EGFR-Mutant Advanced NSCLC
China20 participantsStarted 2026-07-13
Plain-language summary
This is a single-arm clinical study evaluating the safety, tolerability, and preliminary efficacy of JS212 in combination with JS111 as first-line treatment in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for advanced disease.
The study consists of a safety lead-in stage followed by a clinical expansion stage. Approximately 20 participants are planned to be enrolled across the two stages. Participants will receive JS212 by intravenous infusion on Day 1 of each 21-day cycle and JS111 at 160 mg orally once daily until treatment discontinuation criteria are met.
During the safety lead-in stage, up to 10 participants will be enrolled and monitored for significant toxicities during the first 21 days after initial administration. The Safety Monitoring Committee (SMC) will review available safety, tolerability, and efficacy data and determine the JS212 dose to be further evaluated, whether an additional higher or lower dose should be explored, and whether the study may proceed to the clinical expansion stage.
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
. Male or female participants aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
. Histologically or cytologically confirmed recurrent or metastatic solid tumor that is unresectable and not amenable to curative radiotherapy or chemoradiotherapy.
. Confirmed EGFR-sensitizing mutation, defined as an exon 19 deletion or L858R mutation, either occurring alone or together with other EGFR mutations, including concomitant T790M mutation. Local laboratory test reports are acceptable, provided that testing is performed using a well-validated assay, an assay that has passed external quality assessment, a laboratory qualified for molecular pathology diagnosis or genetic testing, or an assay approved by the National Medical Products Administration (NMPA). Participants must not have received prior systemic antitumor therapy for locally advanced or metastatic nonsquamous NSCLC. Participants with recurrent NSCLC who previously received adjuvant or neoadjuvant therapy, including chemotherapy, radiotherapy, or other treatment, or definitive radiotherapy or chemoradiotherapy, may be enrolled if the interval between the last treatment and disease recurrence is more than 6 months.
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.
. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
. Life expectancy of at least 12 weeks.
. Adequate major organ function.
. Women of childbearing potential (WOCBP) who are sexually active with a nonsterilized male partner must have a negative serum pregnancy test within 7 days before the first dose and must agree to have no plans for pregnancy and to use highly effective contraception from the time of signing the informed consent form until 7 months after the last dose of JS212 or 2 months after the last dose of JS111, whichever contraception period is longer.
Exclusion criteria
. Histologically or cytologically confirmed tumor containing a small-cell lung cancer component, large-cell neuroendocrine carcinoma, sarcomatoid features, or a squamous cell carcinoma component greater than 10%;
. Known leptomeningeal metastases;
. Symptomatic brain parenchymal metastases. Participants with asymptomatic brain metastases may be enrolled if considered stable by the investigator.
. Uncontrolled pleural effusion or pericardial effusion, or ascites requiring repeated drainage once per month or more frequently;
. Spinal cord compression not treated with surgery and/or radiotherapy, or previously diagnosed spinal cord compression without clinical evidence of disease stability for at least 4 weeks before enrollment following treatment.
. Chemotherapy or other systemic antitumor therapy within 3 weeks or 5 half-lives before the first dose, whichever is shorter; small-molecule targeted therapy within 2 weeks before the first dose; or limited-field local radiotherapy, such as palliative radiotherapy for bone metastases, within 2 weeks before the first dose;
. Use of a strong CYP3A inhibitor or inducer within 14 days before the first dose of study treatment, or anticipated need for continued treatment with such medications during the study;
. Current treatment with medications known to prolong the QT interval or potentially cause torsades de pointes, or anticipated need for continued treatment with such medications during the study;