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Advanced Non-small Cell Lung CancerPhase 2NCT06775483

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

A Phase 2 study testing JSKN016 and Docetaxel in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
JSKN016 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
No sites listed yet
Study dates
17 Jan 2025to 30 Nov 2027
Phase
Phase 2
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 years and older
  • 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, 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.
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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

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Li Zhang contact

13902282893

zhangli@sysucc.org.cn

About this study

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.

Read the 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.

Being tested
JSKN016, 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.

  • DocetaxelDrug

    Administered intravenously according to protocol.

Study groups in NCT06775483
Study groupRoleWhat they receive
Part I: Cohort 1（JSKN016）ExperimentalEnrolled 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.
Receives: Drug: JSKN016
Part I: Cohort 2（JSKN016）ExperimentalEnrolled subjects with negative driver genes who have already received immunotherapy. Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016
Part I: Cohort 3（JSKN016）ExperimentalEnrolled subjects with positive driver genes who have failed standard therapy.Receive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016
Part II：Cohort A（JSKN016）ExperimentalReceive JSKN016 monotherapy , administered intravenously at the dosage specified in the protocol.
Receives: Drug: JSKN016
Part II：Cohort B（Docetaxel）Active comparatorReceive Docetaxel monotherapy , administered intravenously at the dosage specified in the protocol.
Receives: Drug: Docetaxel

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 (9)

  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. Cmax of JSKN016

    Maximum (Peak) Observed blood Concentration (Cmax) of JSKN016 Following First Dose

    Measured: Up to 24months

  7. AUC of JSKN016

    The blood PK parameters of JSKN016 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.

    Measured: Up to 24months

  8. Tmax of JSKN016

    Time of Maximum blood Concentration (Tmax) of JSKN016 Following First Dose

    Measured: Up to 24months

  9. 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 posted15 Jan 2025
  2. Study start17 Jan 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Nov 2027 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06775483
Sponsor's protocol ID
JSKN016-201
Status last verified
Jan 2025
First submitted
30 Dec 2024
Last updated
15 Jan 2025
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 2 study testing JSKN016 and Docetaxel in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

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: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT06775483.

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 15 Jan 2025.

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