Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

March 25, 2026 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer. The primary objective of the study is to assess the efficacy and safety of JSKN016 in combination therapy in selected subjects with advanced non-small cell lung cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily participate and sign the informed consent form.
  2. Age ≥ 18 years old, ≤ 75 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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort -1A-a
Receive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Carboplatin
AUC 5, Q3W, administered intravenously according to protocol.
Other Names:
  • Carboplatin Injection
Experimental: Cohort -1A-b
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Furmonertinib Mesylate
160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
Other Names:
  • Furmonertinib Mesylate Tablets
Experimental: Cohort -2
Receive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Docetaxel
60mg/m^2, Q3W, administered intravenously according to protocol.
Other Names:
  • Docetaxel injection
Experimental: Cohort -4
Receive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Pembrolizumab
200mg, Q3W, administered intravenously according to protocol.
Other Names:
  • Pembrolizumab Injection
Experimental: Cohort -1B
Receive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Other Names:
  • Ivonescimab Injection
Experimental: Cohort -3A
Receive JSKN016 in combination with tislelizumab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Tislelizumab
200mg, Q3W, administered intravenously according to protocol.
Other Names:
  • Tislelizumab Injection
Drug: Carboplatin
AUC 5, Q3W, administered intravenously according to protocol.
Other Names:
  • Carboplatin Injection
Experimental: Cohort -3B
Receive JSKN016 in combination with ivonescimab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Ivonescimab
20mg/kg, Q3W, administered intravenously according to protocol.
Other Names:
  • Ivonescimab Injection
Drug: Carboplatin
AUC 5, Q3W, administered intravenously according to protocol.
Other Names:
  • Carboplatin Injection
Experimental: Cohort -5
Receive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Drug: JSKN016
Administered intravenously according to protocol.
Drug: Furmonertinib Mesylate
160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
Other Names:
  • Furmonertinib Mesylate Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety reflected by AE
Time Frame: Up to 24months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Up to 24months
ORR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Up to 24months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DOR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Duration of response (DoR) assessed according to RECIST v1.1.
Up to 24months
DCR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Disease control rate (DCR) assessed according to RECIST v1.1.
Up to 24months
TTR assessed by the investigator per RECIST v1.1
Time Frame: Up to 24months
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Up to 24months
PFS assessed by investigator per RECIST v1.1
Time Frame: Up to 24months
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Up to 24months
OS
Time Frame: Up to 24months
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
Up to 24months
ADA
Time Frame: Up to 24months
Number of subjects with detectable anti-drug antibodies (ADA).
Up to 24months
Peak Plasma Concentration (Cmax)
Time Frame: Up to 24months
The Peak Plasma Concentration (Cmax) of the antibody-drug conjugate (ADC), total antibody and free payload.
Up to 24months
Trough Plasma Concentration (Cmin)
Time Frame: Up to 24 months
The Trough Plasma Concentration (Cmin) of the antibody-drug conjugate (ADC), total antibody and free payload.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Zhang, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSKN016-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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