New drug combo aims to wipe out lung cancer before surgery

NCT ID NCT07493980

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug combination (JSKN016, toripalimab, and carboplatin) given before surgery to people with stage II or III non-small cell lung cancer that can be removed. The goal is to see if the treatment can completely or mostly eliminate the tumor before the operation. About 54 adults will take part, and the study will track how well the cancer responds and how long people live without the disease coming back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The subject is able to understand the informed consent form, voluntarily participate in the study, and has signed the informed consent form. * The subject is ≥18 years and ≤80 years of age on the day of signing the informed consent form; both males and females are eligible. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC), according to the AJCC 9th edition TNM staging system for lung cancer. * The subject has not previously received any anti-tumor therapy, including but not limited to systemic chemotherapy, immunotherapy, targeted therapy, or radiotherapy. Subjects who have received traditional Chinese medicine for anti-tumor indications are permitted to enroll provided a washout period of at least 2 weeks has elapsed. * Tumor tissue genetic testing confirms NSCLC without EGFR sensitizing mutations (19del/L858R) and negative for ALK fusion genes. Note: EGFR status may be determined using cytological or blood-based testing results. For subjects with squamous NSCLC, if EGFR and ALK status are previously unknown, testing is not required prior to enrollment in this study and will be considered negative. * At least one measurable lesion at baseline according to RECIST version 1.1. * Adequate organ function. The following laboratory test results must be obtained within 7 days prior to the first dose (echocardiography is permitted within 28 days prior to the first dose): 1. Bone marrow function (no transfusion of whole blood or blood components within 14 days before the first dose; no hematopoietic growth factors within 7 days before the first dose): Absolute neutrophil count ≥ 1.5 × 10⁹/L Hemoglobin ≥ 90 g/L Platelet count ≥ 100 × 10⁹/L 2. Liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ALT and AST ≤ 3 × ULN 3. Renal function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL/min calculated using the Cockcroft-Gault formula (see Appendix 4) 4. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 5. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography 6. Pulmonary function: Pulmonary function considered adequate for surgery as determined by the investigator. * Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first dose. * The subject is able and willing to comply with study protocol requirements, including study visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: * Histopathological evidence of any small cell carcinoma component, or diagnosis of large cell neuroendocrine carcinoma or sarcomatoid carcinoma. * Presence of another malignancy within 3 years prior to the first dose, except for tumors that have been clinically cured by local treatment and have an extremely low risk of recurrence (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma of the skin, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix, localized prostate cancer, etc.), or tumors with disease-free survival ≥ 3 years after curative treatment and an extremely low risk of recurrence or metastasis (e.g., ductal carcinoma in situ after radical surgery, papillary thyroid carcinoma after radical surgery, etc.). * Insufficient washout from prior treatments before the first dose, including: 1. Use of any investigational drug within 28 days prior to the first dose; 2. Use of traditional Chinese herbal medicine or proprietary Chinese medicine with clear anti-tumor indications within 14 days prior to the first dose; 3. Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days prior to the first dose; 4. Requirement for systemic glucocorticoids (\>10 mg/day prednisone or equivalent doses of other glucocorticoids) for more than 7 consecutive days, or immunosuppressive therapy, within 14 days prior to the first dose. Exceptions include inhaled or topical corticosteroids, or physiologic replacement doses for adrenal insufficiency. Short-term (≤7 days) corticosteroid use is permitted for prophylaxis (e.g., prevention of contrast-agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to allergen exposure); 5. Major surgery (e.g., abdominal or thoracic surgery) within 28 days prior to the first dose, excluding minor procedures such as diagnostic puncture, implantation of infusion devices, or biliary stent placement, or anticipated need for major surgery during the study period; 6. Receipt of live vaccines within 28 days prior to the first dose, or planned administration of live vaccines during the study period. * Presence of interstitial lung disease (ILD) or risk factors related to non-infectious pneumonitis, including: 1. History or current presence of ILD or non-infectious pneumonitis requiring systemic glucocorticoids or other immunosuppressive therapy; 2. Suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging during the screening period. * Presence of active autoimmune disease requiring systemic treatment within the past 2 years (e.g., treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. * Uncontrolled infections, including but not limited to: 1. Active HBV or HCV infection. Patients positive for HBsAg must undergo HBV-DNA testing; if HBV-DNA exceeds the lower limit of detection of the local laboratory, enrollment is permitted provided antiviral therapy is administered. Patients positive for HCV-Ab may be enrolled if HCV-RNA is negative; 2. Severe infection within 4 weeks prior to the first dose, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose; 3. History of immunodeficiency, positive HIV test, or history of acquired immunodeficiency syndrome (AIDS); 4. Known active tuberculosis; 5. Active syphilis. * History of allogeneic bone marrow transplantation or organ transplantation. * Known hypersensitivity to any component of the investigational drug, or a history of severe allergic reactions to other antibody-based therapies. * Pregnant or breastfeeding women, or women planning to become pregnant during the study period. * Known psychiatric disorders, substance abuse, alcohol abuse, or any other condition that, in the investigator's judgment, may affect the safety of study treatment or subject compliance. * Any other disease, treatment, or laboratory abnormality, either past or present, that in the investigator's judgment may interfere with the evaluation of safety or efficacy, prevent full participation in the study, or make participation not in the subject's best interest.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

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Other studies related to the condition(s) this trial covers.