New combo therapy targets tough lung cancers
NCT ID NCT06868732
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug combination (JSKN016 plus other treatments) in 288 people with advanced non-small cell lung cancer that has spread and cannot be removed by surgery. The main goals are to see if the treatment shrinks tumors and to check for side effects. The study is currently recruiting participants in China.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 288 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new antibody boost lung cancer treatment?
- Can Long-Term tucatinib use remain safe for HER2-Positive cancers?
- Can a pill outperform chemo for a Hard-to-Treat lung cancer mutation?
- Can a Triple-Drug combo outsmart Immunotherapy-Resistant lung cancer?