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JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations

NCT06940401 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-14

No results posted yet for this study

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

Interventions

DRUG

JS111 capsules (AP-L1898)

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.

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Suzhou Junjing BioSciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2027-11-05

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940401 on ClinicalTrials.gov