JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations

NCT06940401 | Recruiting Phase 1

• 1 other identifier: JS111-003-I/II-NSCLC
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

NSCLC

Outcome Measures

Primary Outcomes (3)

• AE

  Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance

  up to 3years

• ORR

  ORR

  up to 3years

• RP2D

  RP2D

  up to 3years

Secondary Outcomes (15)

• PFS

  up to 3years

• DCR

  up to 3years

• OS

  up to 3years

• (Cmax)

  up to 6 months

• (Tmax）

  up to 6 months

Study Arms (1)

JS111 capsules (AP-L1898)

EXPERIMENTAL

160 or 240 mg once daily (QD)

Drug: JS111 capsules (AP-L1898)

Interventions

JS111 capsules (AP-L1898) DRUG

In Phase I, approximately 3-12 subjects will be enrolled in each dose group (160 mg QD or 240 mg QD) and receive oral JS111 capsules once daily until any treatment discontinuation criteria are met. After all subjects have completed at least 21 days observation following the first dose, the Safety Monitoring Committee (SMC) will review safety and pharmacokinetic data to make decisions. Phase II will continue enrollment at the RP2D dose level until approximately 30 subjects have been treated at that dose.

JS111 capsules (AP-L1898)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Women of childbearing potential (WOCBP) 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 from informed consent signing until 2 months after the last dose.
• Non-sterilized male subjects with female partners of childbearing potential must agree to use effective contraception (as described in Section 10.3.2) from informed consent signing until 4 months after the last dose and must refrain from sperm donation during this period.
• Willingness to participate and signed informed consent provided by the subject.

You may not qualify if:

• Presence of any of the following disease conditions.
• a. Histologically or cytologically confirmed small cell lung cancer (SCLC) components, large cell neuroendocrine carcinoma, or sarcomatoid features；b. Conditions that may affect oral drug absorption, distribution, metabolism, or excretion (e.g., inability to swallow, severe vomiting, uncontrolled diarrhea, major GI surgery, Crohn's disease, ulcerative colitis)；c. Known leptomeningeal metastasis；d. Symptomatic brain metastases；e. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (e.g., ≥ once per month)；f. Untreated or symptomatic spinal cord compression; or previously treated spinal cord compression not stable for at least 4 weeks before enrollment；
• Prior or concurrent treatments.
• a. Any previous treatment with EGFR-TKIs;b. Use of strong CYP3A inhibitors/inducers within 14 days before the first dose or requirement for such treatment during the study;c. Ongoing treatment with drugs known to prolong QT interval or cause Torsades de Pointes;d. Receipt of any investigational drug within 4 weeks or 5 half-lives (whichever is shorter) before first dosing;e. Concurrent participation in another clinical study, unless it is non-interventional or in follow-up phase;f. Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks before first study drug administration;g. Local radiotherapy within 14 days before the first dose (e.g., palliative radiotherapy for bone metastases);
• 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.
• a. QTcF ≥450 ms for males or ≥470 ms for females (mean of 3 ECGs during screening);b. Clinically significant arrhythmias (e.g., complete left bundle branch block, 3rd-degree AV block, PR interval \>250 ms);c. Risk factors for Torsades de Pointes (e.g., hypokalemia, family history of long QT syndrome or inherited arrhythmias); d. Left ventricular ejection fraction (LVEF) \<50%;
• 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.
• Active tuberculosis or history of active TB within 1 year prior to enrollment; or untreated TB if diagnosed over 1 year ago.
• Active hepatitis B (HBsAg positive and HBV DNA ≥500 U/mL) or hepatitis C (anti-HCV positive and HCV RNA above the detection limit).
• History of other malignancies unless low-risk (5-year survival \>90%) and adequately treated, e.g., basal/squamous cell carcinoma of the skin, in situ cervical or breast cancer, localized prostate cancer, or papillary thyroid carcinoma.
• Pregnant or breastfeeding women, or those planning to become pregnant during the study.

Sponsors & Collaborators

• Suzhou Junjing BioSciences Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Central Study Contacts

kui Zhang, Master

CONTACT

18168028925; kui_zhang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 23, 2025
• Study Start: April 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 5, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)