Actively Recruiting
JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations
Led by Suzhou Junjing BioSciences Co., Ltd. · Updated on 2025-05-14
42
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
S
Suzhou Junjing BioSciences Co., Ltd.
Lead Sponsor
S
Sponsor GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged �3e�3d 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).
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Life expectancy of �3e�3d 12 weeks.
- Adequate function of key organs.
- Women of childbearing potential with non-sterilized male partners must have a negative serum pregnancy test within 7 days prior to first dosing and agree to use effective contraception until 2 months after last dose.
- Non-sterilized male subjects with female partners of childbearing potential must agree to use effective contraception from informed consent signing until 4 months after last dose and must refrain from sperm donation during this period.
- Willingness to participate and signed informed consent provided by the subject.
You will not qualify if you...
- Presence of small cell lung cancer components, large cell neuroendocrine carcinoma, or sarcomatoid features.
- Conditions affecting oral drug absorption, distribution, metabolism, or excretion such as inability to swallow, severe vomiting, uncontrolled diarrhea, major GI surgery, Crohn's disease, or ulcerative colitis.
- Known leptomeningeal metastasis or symptomatic brain metastases.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (once or more per month).
- Untreated or symptomatic spinal cord compression or previously treated spinal cord compression not stable for at least 4 weeks before enrollment.
- Prior treatment with EGFR-TKIs.
- Use of strong CYP3A inhibitors or inducers within 14 days before first dose or requiring such treatment during the study.
- Ongoing treatment with drugs known to prolong QT interval or cause Torsades de Pointes.
- Receipt of any investigational drug within 4 weeks or 5 half-lives before first dosing.
- Concurrent participation in another clinical study unless non-interventional or in follow-up phase.
- Major surgery within 4 weeks before first study drug administration.
- Local radiotherapy within 14 days before first dose.
- Unresolved toxicities from prior anti-tumor therapy not recovered to Grade 1 or less, except alopecia, Grade 2 peripheral neuropathy, or Grade 2 hypothyroidism judged non-risk.
- Known hypersensitivity to study drug or excipients.
- Cardiac abnormalities including prolonged QTcF, significant arrhythmias, risk factors for Torsades de Pointes, or left ventricular ejection fraction below 50%.
- History or suspected interstitial lung disease, drug-induced pneumonitis, idiopathic pulmonary fibrosis, or significant pulmonary diseases except Grade 1 radiation pneumonitis.
- Serious infection within 4 weeks prior to first dosing or active pulmonary inflammation requiring antibiotics within 2 weeks prior to dosing.
- History of immunodeficiency or HIV positivity.
- Active tuberculosis or history within 1 year prior to enrollment, or untreated TB diagnosed over 1 year ago.
- Active hepatitis B or C infections.
- History of other malignancies unless low-risk and adequately treated.
- Pregnant or breastfeeding women or those planning pregnancy during the study.
- Uncontrolled comorbid conditions.
- Serious or uncontrolled ocular disease.
- Any other condition judged by the investigator as potentially leading to early withdrawal from the study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
K
kui Zhang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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