Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study

Overview

This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.

Detailed description

This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.

Interventions

• Drug JSKN016
  Administered intravenously according to protocol.
• Drug Docetaxel
  Administered intravenously according to protocol.

Primary outcome measures

• ORR assessed by the investigator per RECIST v1.1 [Time frame: Up to 24months]
• Safety reflected by AE [Time frame: Up to 24months]

Secondary outcome measures (9)

• DOR assessed by the investigator per RECIST v1.1 [Time frame: Up to 24months]
• DCR assessed by the investigator per RECIST v1.1 [Time frame: Up to 24months]
• TTR assessed by the investigator per RECIST v1.1 [Time frame: Up to 24months]
• PFS assessed by investigator per RECIST v1.1 [Time frame: Up to 24months]
• OS [Time frame: Up to 24months]
• Cmax of JSKN016 [Time frame: Up to 24months]
• AUC of JSKN016 [Time frame: Up to 24months]
• Tmax of JSKN016 [Time frame: Up to 24months]
• ADA [Time frame: Up to 24months]

Eligibility criteria

Inclusion criteria

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 years old, male or female.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Expected survival ≥ 3 months.
• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy, and meets one of the following conditions: EGFR sensitive mutations, and failed treatment with EGFR-TKI; Driver gene negative, treated with PD-1/L1 inhibitors and a platinum-containing chemotherapy and treatment failure; Positive driver gene, failure of corresponding standard therapy;
• At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• Recently archived or fresh tumor tissue samples are available.
• Have good organ function.
• Have no current birth plans and agree to contraception during the trial.

Exclusion criteria

• Presence of any small cell carcinoma component in histopathology.
• Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ.
• Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.
• During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.
• Adequate washout of previous therapy before the first dose.
• Gastrointestinal abnormalities with obvious clinical manifestations.
• Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
• Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.
• Previous treatment with docetaxel.
• Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.
• Previous history of allogeneic bone marrow or organ transplantation.
• Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.
• Pregnant and/or lactating females.
• Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06775483 · JSKN016-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗