JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations (NCT06940401) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations
China44 participantsStarted 2025-04-30
Plain-language summary
To evaluate the safety, tolerability, and preliminary efficacy of JS111 capsules in patients with locally advanced, metastatic, or recurrent NSCLC harboring EGFR mutations;to determine the recommended Phase II dose (RP2D).
Who can participate
Age range
18 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 subjects aged ≥18 years at the time of signing informed consent.
. Histologically or cytologically confirmed locally advanced, metastatic, or recurrent NSCLC that is unresectable and unsuitable for curative chemoradiotherapy.
. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
. Confirmed presence of EGFR-sensitizing mutations (exon 19 deletion or L858R mutation), either alone or co-occurring with other EGFR mutations (including T790M-positive cases). Local laboratory results are acceptable if the test is well-validated, qualified through external quality assessment or molecular diagnostics certification, or approved by NMPA.
. At least one measurable lesion according to RECIST v1.1.
. ECOG performance status of 0 or 1.
. Life expectancy of ≥12 weeks.
. Adequate function of key organs.
Exclusion criteria
. Presence of any of the following disease conditions.
. Prior or concurrent treatments.
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.
. Unresolved toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 per CTCAE, except for alopecia, Grade 2 peripheral neuropathy, or Grade 2 hypothyroidism judged to be non-risk by the investigator.
. Known hypersensitivity to study drug or its excipients.
. Cardiac abnormalities, including.
. History or suspected diagnosis of interstitial lung disease, drug-induced pneumonitis, idiopathic pulmonary fibrosis, or other significant pulmonary diseases (except for ≤ Grade 1 radiation pneumonitis).
. Serious infection (CTCAE \> Grade 2) within 4 weeks prior to first dosing, such as pneumonia requiring hospitalization. Active pulmonary inflammation on baseline imaging or infection symptoms requiring antibiotics within 2 weeks prior to dosing (excluding prophylactic use).
. History of immunodeficiency, including HIV positivity, congenital or acquired immunodeficiency disorders, or history of organ/allogeneic bone marrow transplantation or autologous stem cell transplantation.