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Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients

NCT07493980 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-27

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.

Conditions

  • NSCLC Stage II

Interventions

DRUG

JSKN016 + Toripalimab + Carboplatin

During the neoadjuvant treatment phase, enrolled subjects will receive combination therapy with JSKN016 (4 mg/kg) + toripalimab (240 mg) + carboplatin (AUC 5) in 3-week cycles, with a maximum of 4 cycles. Subjects meeting surgical criteria will undergo surgery within 8 weeks after the last neoadjuvant treatment cycle. A preoperative visit will be conducted 1 week (±1 week) prior to surgery. Surgery may be advanced if the investigator determines the subject is stable and fit for surgery, provided it occurs at least 7 days after the last study drug administration. Resected tumor specimens will undergo assessment of surgical margins and extent of resection (R0, R1/R2). Tumor tissue will be evaluated for pathological response (MPR and pCR). Subsequent adjuvant therapy will follow standard clinical practice.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Chang Chen, MD, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-01-31
Completion
2029-01-01

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 NCT07493980 on ClinicalTrials.gov