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Advanced Non-small Cell Lung CancerPhase 1NCT06868732

Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

A Phase 1 study testing JSKN016, Carboplatin and Furmonertinib Mesylate in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
JSKN016, Carboplatin and Furmonertinib Mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
1 siteChina
Study dates
2 Apr 2025to 30 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate and sign the informed consent form.
  • Age ≥ 18 years old, ≤ 75 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.
  • At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Zhang contact

13902282893

zhangli@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Li Zhang, 020-87343458, zhangli@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
JSKN016, Carboplatin, Furmonertinib Mesylate, Ivonescimab, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN016Drug

    Administered intravenously according to protocol.

  • CarboplatinDrug

    Also called Carboplatin Injection

    AUC 5, Q3W, administered intravenously according to protocol.

  • Furmonertinib MesylateDrug

    Also called Furmonertinib Mesylate Tablets

    160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.

  • IvonescimabDrug

    Also called Ivonescimab Injection

    20mg/kg, Q3W, administered intravenously according to protocol.

  • DocetaxelDrug

    Also called Docetaxel injection

    60mg/m^2, Q3W, administered intravenously according to protocol.

  • TislelizumabDrug

    Also called Tislelizumab Injection

    200mg, Q3W, administered intravenously according to protocol.

  • PembrolizumabDrug

    Also called Pembrolizumab Injection

    200mg, Q3W, administered intravenously according to protocol.

Study groups in NCT06868732
Study groupRoleWhat they receive
Cohort -1A-aExperimentalReceive JSKN016 in combination with carboplatin, administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Carboplatin
Cohort -1A-bExperimentalReceive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Furmonertinib Mesylate
Cohort -1BExperimentalReceive JSKN016 in combination with ivonescimab, administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Ivonescimab
Cohort -2ExperimentalReceive JSKN016 in combination with docetaxel, administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Docetaxel
Cohort -3AExperimentalReceive JSKN016 in combination with tislelizumab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Carboplatin; Drug: Tislelizumab
Cohort -3BExperimentalReceive JSKN016 in combination with ivonescimab，with or without carboplatin, administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Carboplatin; Drug: Ivonescimab
Cohort -4ExperimentalReceive JSKN016 in combination with pembrolizumab, administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Pembrolizumab
Cohort -5ExperimentalReceive JSKN016 in combination with furmonertinib mesilate tablets, administered at the dosage specified in the protocol.
Receives: Drug: JSKN016; Drug: Furmonertinib Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR assessed by the investigator per RECIST v1.1

    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)

    Measured: Up to 24months

  2. Safety reflected by AE

    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.

    Measured: Up to 24months

Secondary outcomes (8)

  1. DOR assessed by the investigator per RECIST v1.1

    Duration of response (DoR) assessed according to RECIST v1.1.

    Measured: Up to 24months

  2. DCR assessed by the investigator per RECIST v1.1

    Disease control rate (DCR) assessed according to RECIST v1.1.

    Measured: Up to 24months

  3. TTR assessed by the investigator per RECIST v1.1

    Time to response (TTR) is defined as the time to response base on RECIST v1.1.

    Measured: Up to 24months

  4. PFS assessed by investigator per RECIST v1.1

    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).

    Measured: Up to 24months

  5. OS

    Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.

    Measured: Up to 24months

  6. Peak Plasma Concentration (Cmax)

    The Peak Plasma Concentration (Cmax) of the antibody-drug conjugate (ADC), total antibody and free payload.

    Measured: Up to 24months

  7. Trough Plasma Concentration (Cmin)

    The Trough Plasma Concentration (Cmin) of the antibody-drug conjugate (ADC), total antibody and free payload.

    Measured: Up to 24 months

  8. ADA

    Number of subjects with detectable anti-drug antibodies (ADA).

    Measured: Up to 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start2 Apr 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868732
Sponsor's protocol ID
JSKN016-102
Status last verified
Mar 2025
First submitted
5 Mar 2025
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JSKN016, Carboplatin and Furmonertinib Mesylate in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Zhang (13902282893, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR assessed by the investigator per RECIST v1.1 (time frame: Up to 24months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06868732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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