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JS212 in Combination With JS111 as First-Line Treatment in EGFR-Mutant Advanced NSCLC

NCT07714304 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-20

No results posted yet for this study

Summary

This is a single-arm clinical study evaluating the safety, tolerability, and preliminary efficacy of JS212 in combination with JS111 as first-line treatment in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for advanced disease.

The study consists of a safety lead-in stage followed by a clinical expansion stage. Approximately 20 participants are planned to be enrolled across the two stages. Participants will receive JS212 by intravenous infusion on Day 1 of each 21-day cycle and JS111 at 160 mg orally once daily until treatment discontinuation criteria are met.

During the safety lead-in stage, up to 10 participants will be enrolled and monitored for significant toxicities during the first 21 days after initial administration. The Safety Monitoring Committee (SMC) will review available safety, tolerability, and efficacy data and determine the JS212 dose to be further evaluated, whether an additional higher or lower dose should be explored, and whether the study may proceed to the clinical expansion stage.

Conditions

  • NSCLC Harboring EGFR Mutations

Interventions

DRUG

JS212 for Injection

Administered by intravenous infusion on Day 1 of each 21-day cycle.

DRUG

JS111 capsules (AP-L1898)

160 mg once daily (QD)

Sponsors & Collaborators

  • Huan Zhou

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2026-11-13
Completion
2029-07-23

Countries

  • China

Study Locations

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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 NCT07714304 on ClinicalTrials.gov