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NSCLCPhase 1/2NCT06940401

JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations

A Phase 1/2 study testing JS111 capsules (AP-L1898) in people with NSCLC, run by Suzhou Junjing BioSciences Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
JS111 capsules (AP-L1898)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
30 Apr 2025to 30 Sep 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Presence of any of the following disease conditions.
  • 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.
  • 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.
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  • Cardiac abnormalities, including.
  • 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.
  • Uncontrolled comorbid conditions.
  • Any serious or uncontrolled ocular disease.
  • Any other condition judged by the investigator as potentially leading to early withdrawal from the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Phase I/II Clinical Study to Evaluate JS111 Capsules in Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations.

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).

Read the detailed description

This is a Phase II clinical study evaluating JS111 capsules (AP-L1898) as monotherapy in patients with advanced NSCLC harboring EGFR mutations.Approximately 3 to 42 treatment-naïve patients with EGFR mutation-positive locally advanced, metastatic, or recurrent NSCLC will be enrolled.Based on prior safety, PK, and efficacy data, two dose levels-160 mg QD and 240 mg QD-will be tested to assess safety, tolerability, PK, and preliminary efficacy, and to determine the recommended Phase II dose (RP2D), as referenced in Section 4.3.

The study includes two parts:

Part 1:

Each dose group will enroll 3-12 subjects who will receive oral JS111 capsules daily until meeting treatment discontinuation criteria. Once all subjects complete at least the Day 21 observation following the first dose 21 days of treatment , the Safety Monitoring Committee (SMC) will review the data to decide whether to:

  1. Select RP2D for further enrollment;
  2. Continue enrollment for further evaluation;
  3. Explore other dose levels;
  4. Amend or terminate the study if needed. Subjects who receive <80% of planned doses or discontinue for non-drug-related reasons during the 21-day period will be replaced. Mutation subtypes (exon 19 deletion or exon 21 L858R) will be evenly assigned across dose groups, starting from the lower dose.

Part 2:

Subjects will be enrolled into the RP2D cohort until ~30 patients have been treated with the dose. Subjects from the other group may continue on the same dose or switch to RP2D as appropriate. JS111 will be taken once daily in 21-day cycles to further assess safety, PK, and preliminary efficacy.

Conditions
NSCLC
Being tested
JS111 capsules (AP-L1898)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06940401
Study groupRoleWhat they receive
JS111 capsules (AP-L1898)Experimental160 or 240 mg once daily (QD)
Receives: Drug: JS111 capsules (AP-L1898)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE

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

    Measured: up to 3years

  2. ORR

    ORR

    Measured: up to 3years

  3. RP2D

    RP2D

    Measured: up to 3years

Secondary outcomes (15)

  1. PFS

    Progression-free survival (PFS)

    Measured: up to 3years

  2. DCR

    disease control rate (DCR)

    Measured: up to 3years

  3. OS

    overall survival (OS)

    Measured: up to 3years

  4. (Cmax)

    Evaluation of the first dose peak concentration (Cmax)

    Measured: up to 6 months

  5. (Tmax）

    Evaluation of the first dose time to peak (Tmax)

    Measured: up to 6 months

  6. (AUC0-t）

    Evaluation of the area under the concentration-time curve (AUC0-t) for the first dose

    Measured: up to 6 months

  7. (t1/2）

    Assessment of the first dose elimination half-life (T 1/2)

    Measured: up to 6 months

  8. (CL/F）

    Assessment of apparent clearance rate of the first dose (CL/F)

    Measured: up to 6 months

  9. (Vd/F）

    Assessment of apparent volume distribution (Vd/F) for the first dose

    Measured: up to 6 months

  10. (λz）

    Evaluation of the first dose elimination rate constant (λz)

    Measured: up to 6 months

  11. (Cmin, ss）

    Assessment of steady-state trough concentration (Cmin, ss) for multiple doses

    Measured: up to 6 months

  12. (Cmax, ss）

    Assessment of steady-state peak concentration (Cmax, ss) for multiple doses

    Measured: up to 6 months

  13. (Cavg, ss）

    Assessment of mean steady-state plasma concentrations (Cavg, ss) for multiple doses

    Measured: up to 6 months

  14. Plasma concentrations of JS111

    Evaluation of plasma concentrations of JS111

    Measured: up to 6 months

  15. Plasma concentrations of JS111 active metabolite M546b

    Evaluation of plasma concentrations of JS111 active metabolite M546b

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start30 Apr 2025
  3. Primary completion30 Jul 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940401
Sponsor's protocol ID
JS111-003-I/II-NSCLC
Status last verified
Jul 2026
First submitted
8 Apr 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JS111 capsules (AP-L1898) in people with NSCLC, run by Suzhou Junjing BioSciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE (time frame: up to 3years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940401.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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