NSCLC Stage IIPhase 2NCT07493980
Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients
A Phase 2 study testing JSKN016 + Toripalimab + Carboplatin in people with NSCLC Stage II, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC Stage II
- What is being tested?
- JSKN016 + Toripalimab + Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to 1 Jan 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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):
- 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
- Liver function:
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ALT and AST ≤ 3 × ULN
- Renal function:
- Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL/min calculated using the Cockcroft-Gault formula (see Appendix 4)
- Coagulation function:
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Cardiac function:
- Left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography
- 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.
Who cannot join
- 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:
- Use of any investigational drug within 28 days prior to the first dose;
- Use of traditional Chinese herbal medicine or proprietary Chinese medicine with clear anti-tumor indications within 14 days prior to the first dose;
- Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days prior to the first dose;
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- 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);
- 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;
- 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:
- History or current presence of ILD or non-infectious pneumonitis requiring systemic glucocorticoids or other immunosuppressive therapy;
- 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:
- 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;
- 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;
- History of immunodeficiency, positive HIV test, or history of acquired immunodeficiency syndrome (AIDS);
- Known active tuberculosis;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Chang Chen, MD, PhD, 86-021-65115006 ext. 2074, chenthoracic@163.com
About this study
Official title: Study on the Efficacy and Safety of JSKN016 Combined With Toripalimab and Carboplatin as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients
This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.
Read the detailed description
Enrolled subjects were histologically confirmed resectable stage II, IIIA, and IIIB NSCLC (according to the 9th edition AJCC Lung Cancer TNM Staging System), with no evidence of distant metastasis and no evidence of unresectable local regional tumor extension.
- Conditions
- NSCLC Stage II
- Being tested
- JSKN016 + Toripalimab + Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN016 + Toripalimab + CarboplatinDrug
During the neoadjuvant treatment phase, enrolled subjects will receive combination therapy with JSKN016 (4 mg/kg) + toripalimab (240 mg) + carboplatin (AUC 5) in 3-week cycles, with a maximum of 4 cycles. Subjects meeting surgical criteria will undergo surgery within 8 weeks after the last neoadjuvant treatment cycle. A preoperative visit will be conducted 1 week (±1 week) prior to surgery. Surgery may be advanced if the investigator determines the subject is stable and fit for surgery, provided it occurs at least 7 days after the last study drug administration. Resected tumor specimens will undergo assessment of surgical margins and extent of resection (R0, R1/R2). Tumor tissue will be evaluated for pathological response (MPR and pCR). Subsequent adjuvant therapy will follow standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| JSKN016+Toripalimab+Carboplatin | Experimental | Not described Receives: Drug: JSKN016 + Toripalimab + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (PCR) Rate
PCR is defined as the absence of any viable tumor cells in the primary tumor site and all sampled lymph node regions of the resected specimen after neoadjuvant therapy, as confirmed by complete pathological assessment.
Measured: About 5 months after enrollment
Secondary outcomes (7)
Major Pathological Response (MPR) Rate
MPR is defined as the proportion of viable tumor cells in the resected primary tumor site after neoadjuvant therapy being ≤ 10%.
Measured: about 5 months after enrollment
Event-Free Survival (EFS)
Measured: up to 4 years
Overall survival (OS)
Measured: Up to 4 years
Disease Control Rate(DCR)
Disease Control Rate (DCR) refers to the proportion of patients whose tumors or diseases achieve "Complete Response (CR)," "Partial Response (PR)," or "Stable Disease (SD)" (according to RECIST1.1) after receiving drug treatment
Measured: About 4-5 months after enrollment
Surgery Completion Rate
The proportion of subjects who underwent lung cancer resection among those receiving the therapy.
Measured: Up to 8 weeks after administration of the final neoadjuvant therapy dose
R0 Resection Rate
The proportion of subjects who underwent lung cancer resection and achieved complete resection (R0) among those receiving the therapy.
Measured: About 5 months after enrollment
Safety and Tolerability
Number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v6.0.
Measured: From the subject's written consent to participate in the study through 30 days after the final administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chang Chen, MD, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493980
- Sponsor's protocol ID
- STAR-019
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of JSKN016 Combined With Toripalimab and Carboplatin as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07493980
- Acronym / sponsor ID
- STAR-019
- Conditions
- NSCLC Stage II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.
Detailed description
Enrolled subjects were histologically confirmed resectable stage II, IIIA, and IIIB NSCLC (according to the 9th edition AJCC Lung Cancer TNM Staging System), with no evidence of distant metastasis and no evidence of unresectable local regional tumor extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JSKN016+Toripalimab+Carboplatin | Experimental | Drug: JSKN016 + Toripalimab + Carboplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (27 listed)
- 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:
- 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);
- Presence of interstitial lung disease (ILD) or risk factors related to non-infectious pneumonitis, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JSKN016 + Toripalimab + CarboplatinDuring the neoadjuvant treatment phase, enrolled subjects will receive combination therapy with JSKN016 (4 mg/kg) + toripalimab (240 mg) + carboplatin (AUC 5) in 3-week cycles, with a maximum of 4 cycles. Subjects meeting surgical criteria will undergo surgery within 8 weeks after the last neoadjuvant treatment cycle. A preoperative visit will be conducted 1 week (±1 week) prior to surgery. Surgery may be advanced if the investigator determines the subject is stable and fit for surgery, provided it occurs at least 7 days after the last study drug administration. Resected tumor specimens will undergo assessment of surgical margins and extent of resection (R0, R1/R2). Tumor tissue will be evaluated for pathological response (MPR and pCR). Subsequent adjuvant therapy will follow standard clinical practice. | Drug | JSKN016+Toripalimab+Carboplatin |
Primary outcome
Pathological Complete Response (PCR) Rate
Time frame: About 5 months after enrollment
PCR is defined as the absence of any viable tumor cells in the primary tumor site and all sampled lymph node regions of the resected specimen after neoadjuvant therapy, as confirmed by complete pathological assessment.
7 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: about 5 months after enrollment
Event-Free Survival (EFS)
Time frame: up to 4 years
Overall survival (OS)
Time frame: Up to 4 years
Disease Control Rate(DCR)
Time frame: About 4-5 months after enrollment
Surgery Completion Rate
Time frame: Up to 8 weeks after administration of the final neoadjuvant therapy dose
R0 Resection Rate
Time frame: About 5 months after enrollment
Safety and Tolerability
Time frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chang Chen, MD, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JSKN016 + Toripalimab + Carboplatin in people with NSCLC Stage II, run by Shanghai Pulmonary Hospital, Shanghai, China 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 23 inclusion and 27 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 27 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 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 Junqi Wu, MD (86-19102122052, wujq0724@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (PCR) Rate (time frame: About 5 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.