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

NCT ID: NCT06775483

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2027-11-30

Brief Summary

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.

Conditions

Advanced Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part I: Cohort 1（JSKN016）

Enrolled subjects with harboring sensitive EGFR mutations who have already received tyrosine kinase inhibitor (TKI) therapy.Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.

Group Type: EXPERIMENTAL

JSKN016

Intervention Type: DRUG

Administered intravenously according to protocol.

Part I: Cohort 2（JSKN016）

Enrolled subjects with negative driver genes who have already received immunotherapy. Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.

Group Type: EXPERIMENTAL

JSKN016

Intervention Type: DRUG

Administered intravenously according to protocol.

Part I: Cohort 3（JSKN016）

Enrolled subjects with positive driver genes who have failed standard therapy.Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.

Group Type: EXPERIMENTAL

JSKN016

Intervention Type: DRUG

Administered intravenously according to protocol.

Part II：Cohort A（JSKN016）

Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.

Group Type: EXPERIMENTAL

JSKN016

Intervention Type: DRUG

Administered intravenously according to protocol.

Part II：Cohort B（Docetaxel）

Receive Docetaxel monotherapy , administered intravenously at the dosage specified in the protocol.

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Administered intravenously according to protocol.

Interventions

JSKN016

Administered intravenously according to protocol.

Intervention Type: DRUG

Docetaxel

Administered intravenously according to protocol.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily participate and sign the informed consent form.

2. Age ≥ 18 years old, male or female.

3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

4. Expected survival ≥ 3 months.

5. 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;

6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.

7. Recently archived or fresh tumor tissue samples are available.

8. Have good organ function.

9. Have no current birth plans and agree to contraception during the trial.

Exclusion Criteria

1. Presence of any small cell carcinoma component in histopathology.

2. 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.

3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.

4. 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.

5. Adequate washout of previous therapy before the first dose.

6. Gastrointestinal abnormalities with obvious clinical manifestations.

7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.

8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.

9. 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.

10. Previous treatment with docetaxel.

11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.

12. Previous history of allogeneic bone marrow or organ transplantation.

13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.

14. Pregnant and/or lactating females.

15. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Central Contacts

Li Zhang

Role: CONTACT

zhangli@sysucc.org.cn

13902282893

Other Identifiers

JSKN016-201

Identifier Type: -

Identifier Source: org_study_id