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

NCT07493980 | Not Yet Recruiting Phase 2

• 1 other identifier: STAR-019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (PCR) Rate

  PCR is defined as the absence of any viable tumor cells in the primary tumor site and all sampled lymph node regions of the resected specimen after neoadjuvant therapy, as confirmed by complete pathological assessment.

  About 5 months after enrollment

Secondary Outcomes (7)

• Major Pathological Response (MPR) Rate

  about 5 months after enrollment

• Event-Free Survival (EFS)

  up to 4 years

• Overall survival (OS)

  Up to 4 years

• Disease Control Rate(DCR)

  About 4-5 months after enrollment

• Surgery Completion Rate

  Up to 8 weeks after administration of the final neoadjuvant therapy dose

Study Arms (1)

JSKN016+Toripalimab+Carboplatin

EXPERIMENTAL

Drug: JSKN016 + Toripalimab + Carboplatin

Interventions

JSKN016 + Toripalimab + Carboplatin DRUG

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.

JSKN016+Toripalimab+Carboplatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is able to understand the informed consent form, voluntarily participate in the study, and has signed the informed consent form.
• The subject is ≥18 years and ≤80 years of age on the day of signing the informed consent form; both males and females are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically or cytologically confirmed resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC), according to the AJCC 9th edition TNM staging system for lung cancer.
• The subject has not previously received any anti-tumor therapy, including but not limited to systemic chemotherapy, immunotherapy, targeted therapy, or radiotherapy. Subjects who have received traditional Chinese medicine for anti-tumor indications are permitted to enroll provided a washout period of at least 2 weeks has elapsed.
• Tumor tissue genetic testing confirms NSCLC without EGFR sensitizing mutations (19del/L858R) and negative for ALK fusion genes.
• Note: EGFR status may be determined using cytological or blood-based testing results. For subjects with squamous NSCLC, if EGFR and ALK status are previously unknown, testing is not required prior to enrollment in this study and will be considered negative.
• At least one measurable lesion at baseline according to RECIST version 1.1.
• Adequate organ function. The following laboratory test results must be obtained within 7 days prior to the first dose (echocardiography is permitted within 28 days prior to the first dose):
• Bone marrow function (no transfusion of whole blood or blood components within 14 days before the first dose; no hematopoietic growth factors within 7 days before the first dose):
• Absolute neutrophil count ≥ 1.5 × 10⁹/L Hemoglobin ≥ 90 g/L Platelet count ≥ 100 × 10⁹/L
• Liver function:
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ALT and AST ≤ 3 × ULN
• Renal function:
• Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL/min calculated using the Cockcroft-Gault formula (see Appendix 4)

You may not qualify if:

• Histopathological evidence of any small cell carcinoma component, or diagnosis of large cell neuroendocrine carcinoma or sarcomatoid carcinoma.
• Presence of another malignancy within 3 years prior to the first dose, except for tumors that have been clinically cured by local treatment and have an extremely low risk of recurrence (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma of the skin, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix, localized prostate cancer, etc.), or tumors with disease-free survival ≥ 3 years after curative treatment and an extremely low risk of recurrence or metastasis (e.g., ductal carcinoma in situ after radical surgery, papillary thyroid carcinoma after radical surgery, etc.).
• Insufficient washout from prior treatments before the first dose, including:
• Use of any investigational drug within 28 days prior to the first dose;
• Use of traditional Chinese herbal medicine or proprietary Chinese medicine with clear anti-tumor indications within 14 days prior to the first dose;
• Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days prior to the first dose;
• Requirement for systemic glucocorticoids (\>10 mg/day prednisone or equivalent doses of other glucocorticoids) for more than 7 consecutive days, or immunosuppressive therapy, within 14 days prior to the first dose.
• Exceptions include inhaled or topical corticosteroids, or physiologic replacement doses for adrenal insufficiency. Short-term (≤7 days) corticosteroid use is permitted for prophylaxis (e.g., prevention of contrast-agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to allergen exposure);
• Major surgery (e.g., abdominal or thoracic surgery) within 28 days prior to the first dose, excluding minor procedures such as diagnostic puncture, implantation of infusion devices, or biliary stent placement, or anticipated need for major surgery during the study period;
• Receipt of live vaccines within 28 days prior to the first dose, or planned administration of live vaccines during the study period.
• Presence of interstitial lung disease (ILD) or risk factors related to non-infectious pneumonitis, including:
• History or current presence of ILD or non-infectious pneumonitis requiring systemic glucocorticoids or other immunosuppressive therapy;
• Suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging during the screening period.
• Presence of active autoimmune disease requiring systemic treatment within the past 2 years (e.g., treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs).
• Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Chang Chen, MD, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junqi Wu, MD

CONTACT

86-19102122052; wujq0724@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，phD

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)