Non Small Cell Lung Cancer (Stage III)Phase 2NCT06706219

Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLC

A Phase 2 study testing Sacituzumab tirumotecan plus toripalimab in people with Non Small Cell Lung Cancer (Stage III), run by Hunan Province Tumor Hospital at 1 site in China.

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

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Non Small Cell Lung Cancer (Stage III)
What is being tested?: Sacituzumab tirumotecan plus toripalimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 10 May 2026to 31 Dec 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who voluntarily participate in this clinical study, understand the study procedures and are able to sign the informed consent form in writing;
Men or women aged 18-70 years (inclusive) at the time of signing the informed consent form.
ECOG PS score of 0 or 1.
Histologically or cytologically confirmed stage III non-small cell lung cancer that cannot be surgically treated as determined by the investigator. Disease staging should be based on the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) NSCLC staging system, 8th edition.
Ability to provide tumor tissue specimens, either archived within 6 months prior to the first dose of study drug or freshly obtained. See the laboratory manual for specific requirements.
Pulmonary function of at least FEV1 > 1.0 L and FEV1% > 40% within 3 months.

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Patients must have measurable target lesions examined by CT or MRI per RECIST v1.1 criteria. Tumor imaging assessments are performed within 28 days prior to the first dose.
Adequate hematologic and vital organ functions, as defined by the following laboratory findings, which need to be completed within 14 days prior to the first study treatment:
(1). Hematology (no hematopoietic stimulating factor drugs or blood transfusion within 14 days before the first study treatment): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, absolute lymphocyte count (LC) ≥ 0.5 × 109/L; platelet count (PLT) ≥ 100 × 109/L, hemoglobin (Hb) ≥ 90 g/L (2). Liver function: aspartate transferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; ; serum total bilirubin (TBIL) ≤ 1.5 x ULN (total bilirubin ≤ 3.0 mg/dL in patients with confirmed Gilbert syndrome); albumin (ALB) ≥ 3 g/dL; (3). Renal function: creatinine clearance rate (CrCl) ≥ 45 mL/minute (by Cockcroft-Gault formula); (4). Coagulation: international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN; (5). Cardiac color ultrasound: left ventricular ejection fraction (LVEF) ≥ 50% 9.Female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 72 hours prior to receiving the study drug. Reliable contraception, such as intrauterine devices, oral contraceptives, or condoms, must be used during the trial and for 90 days following the final dose. Male participants with partners of childbearing potential must use condoms during the trial and for 30 days following the study's conclusion.

Who cannot join

Histologically or cytologically confirmed mixed small cell and non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
Patients with EGFR gene mutations or ALK/ROS1 gene rearrangements.
Prior systemic anti-tumor therapy for NSCLC (including investigational agents in clinical trials) or prior thoracic radiotherapy.
History of other malignancies within 3 years prior to the first dose, except for those cured by local therapy (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).
Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose; (2) History of myocardial diseases, including myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis (DVT) within 3 months prior to the first dose (enrollment is permitted if DVT has been stabilized with low molecular weight heparin or equivalent therapy for ≥2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events; (4) Presence of aortic aneurysm, aortic dissection, or other major vascular diseases that are potentially life-threatening or requiring surgical intervention within 6 months prior to the first dose
Uncontrolled systemic diseases as judged by the investigator, including but not limited to: (1) Poorly controlled diabetes mellitus (fasting blood glucose ≥10 mmol/L on two consecutive measurements); (2) Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).

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History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis at screening that cannot be excluded by imaging.
Clinically significant pulmonary impairment caused by pulmonary comorbidities, including but not limited to any underlying pulmonary conditions (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage.
Active autoimmune diseases requiring systemic therapy within the past 2 years (including but not limited to autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); systemic therapy is defined as disease-modifying agents, immunosuppressants, or systemic corticosteroids (>10 mg/day prednisone or equivalent). Note: Hormone replacement therapies, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, are not considered systemic therapies. Patients who have received systemic corticosteroid therapy at a dose of >10 mg/day prednisone or equivalent, or other immunosuppressive medications within 2 weeks prior to the first dose are excluded.
Known active pulmonary tuberculosis (TB). Subjects with suspected active TB must undergo clinical evaluation to rule out the diagnosis.
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Active hepatitis B [hepatitis B surface antigen (HBsAg) positive with HBV-DNA ≥500 IU/mL or above the lower limit of detection (whichever is higher)] or active hepatitis C [hepatitis C antibody positive with HCV-RNA above the lower limit of detection]. Note: HBsAg-positive subjects are required to receive anti-HBV antiviral therapy throughout the study treatment period.
Known positive human immunodeficiency virus (HIV) test result or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
Known hypersensitivity to disitamab vedotin, toripalimab, platinum-based agents, pemetrexed, paclitaxel, docetaxel, or any of their excipients (including polysorbate-20); known history of severe hypersensitivity reactions to other monoclonal antibodies.
Major surgical procedure within 4 weeks prior to the first dose, or anticipated need for major surgery during the study period.
Serious infection within 4 weeks prior to the first dose, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose.
Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or approved traditional Chinese medicine preparations with anti-tumor indications within 2 weeks prior to the first dose.
Administration of a live vaccine within 30 days prior to the first dose, or planned live vaccination during the study period.
Rapid disease deterioration observed during the screening period prior to the first dose, such as significant decline in performance status.
Pregnant or breastfeeding women.
Presence of local or systemic diseases attributable to non-malignant causes, or conditions secondary to the tumor, that may confer significant medical risk and/or uncertainty in survival assessment, such as leukemoid reaction or cachexia.
Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that impairs delayed corneal healing.
Any condition that, in the opinion of the investigator, may interfere with the evaluation of the investigational drug, compromise patient safety, or confound the interpretation of study results; or any other condition deemed by the investigator to render the subject unsuitable for participation in this study.

Trial locations and contacts

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

Yongchang Zhang, MD contact

+8613873123436

zhangyongchang@csu.edu.cn

China1 site

Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013
Yongchang Zhang, MD, +8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn

Other trials in China

About this study

Official title: Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Phase II Study

Read the detailed description

This study is a phase 2 open-label, single-center clinical study to evaluate the efficacy and safety SKB264 in combination with toripalimab in patients with unresectable stage III non-small cell lung cancer. The study includes a screening period (up to 28 days after the subject signs the informed consent form until before the first dose), a treatment period (including an induction treatment period, a local treatment period (surgery or radical radiotherapy), and a consolidation treatment period), and a follow-up period (including two parts of safety follow-up and survival follow-up). Approximately 50 patients with initially unresectable stage III non-small cell lung cancer patients, without EGFR/ALK/ROS-1-sensitive mutations, without chest radiotherapy and systemic anti-tumor therapy, were enrolled

Conditions: Non Small Cell Lung Cancer (Stage III)
Being tested: Sacituzumab tirumotecan plus toripalimab
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.

Sacituzumab tirumotecan plus toripalimabDrug
Participants meeting the inclusion criteria will receive toripalimab (240 mg, IV) + SKB264 (4mg/kg, IV) for 12 weeks as induction therapy. Patients who undergo surgical resection will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for up to 13 cycles.
Patients who receive definitive concurrent chemoradiotherapy will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for a maximum duration of 1 year.

Study groups in NCT06706219
Study group	Role	What they receive
Sacituzumab tirumotecan (SKB264) in combination with toripalimab	Experimental	Not described Receives: Drug: Sacituzumab tirumotecan plus toripalimab

What is being measured

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

18m EFS rate
18-month progression-free survival (PFS) rate
Measured: Time from the first dose treatment to 18 months
Surgical Conversion Rate
The Surgical Resection Rate is defined as the proportion of subjects who successfully undergo surgical resection after completing the induction therapy phase
Measured: From enrollment until 8 weeks after completion of induction therapy

Secondary outcomes (7)

Event-free survival (EFS)
Defined as the time from the first dose treatment to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Measured: Time from first subject enrollment to study completion, or up to 60 months
R0 surgical resection rate
No residual ratio under the microscope after surgical resection
Measured: Time from the first subject dose to study completion, or up to 60 months
Complete Response (pCR) rate
Defined as the absence of active tumors in lesions at the time of surgical resection of primary tumors.
Measured: Time from the first subject dose to study completion, or up to 60 months
Major Pathological Response (MPR) rate
Defined as the incidence of ≤10% active tumors in lesions at the time of surgical resection of primary tumors.
Measured: Time from the first subject dose to study completion, or up to 60 months
Objective response rate (ORR)
The ORR of ITT after SKB264 combined with toripalimab was evaluated according to Solid Tumor Response Assessment Criteria version 1.1, defined as the proportion of subjects who were evaluated for complete response and partial response after induce treatment
Measured: Time from the first subject dose to study completion, or up to 60 months
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: From the first dose to 28 days after the last dose, until 36 months
Overall survival (OS)
Defined as the time from the first dose treatment to death.
Measured: Time from the first subject dose to study completion, or up to 60 months

Timeline

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

10 May 202631 Dec 2029

First posted26 Nov 2024
Study start10 May 2026 (estimated)
Primary completion30 Nov 2028 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Small Cell Lung Cancer (Stage III)Studies of the same condition, open and under way.
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: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06706219
Sponsor's protocol ID: SUPER-01
Status last verified: Mar 2026
First submitted: 23 Nov 2024
Last updated: 3 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Phase II Study
ClinicalTrials.gov ID: NCT06706219
Acronym / sponsor ID: SUPER-01
Conditions: Non Small Cell Lung Cancer (Stage III)
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Hunan Province Tumor HospitalUniversity, hospital or other
Study start: 10 May 2026 (estimated)
Primary completion: 30 Nov 2028 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 26 Nov 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sacituzumab tirumotecan (SKB264) in combination with toripalimab	Experimental	Drug: Sacituzumab tirumotecan plus toripalimab

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients who voluntarily participate in this clinical study, understand the study procedures and are able to sign the informed consent form in writing;
Men or women aged 18-70 years (inclusive) at the time of signing the informed consent form.
ECOG PS score of 0 or 1.
Histologically or cytologically confirmed stage III non-small cell lung cancer that cannot be surgically treated as determined by the investigator. Disease staging should be based on the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) NSCLC staging system, 8th edition.
Ability to provide tumor tissue specimens, either archived within 6 months prior to the first dose of study drug or freshly obtained. See the laboratory manual for specific requirements.

Key exclusion criteria (24 listed)

Histologically or cytologically confirmed mixed small cell and non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
Patients with EGFR gene mutations or ALK/ROS1 gene rearrangements.
Prior systemic anti-tumor therapy for NSCLC (including investigational agents in clinical trials) or prior thoracic radiotherapy.
History of other malignancies within 3 years prior to the first dose, except for those cured by local therapy (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).
Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose; (2) History of myocardial diseases, including myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis (DVT) within 3 months prior to the first dose (enrollment is permitted if DVT has been stabilized with low molecular weight heparin or equivalent therapy for ≥2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events; (4) Presence of aortic aneurysm, aortic dissection, or other major vascular diseases that are potentially life-threatening or requiring surgical intervention within 6 months prior to the first dose

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
Sacituzumab tirumotecan plus toripalimabParticipants meeting the inclusion criteria will receive toripalimab (240 mg, IV) + SKB264 (4mg/kg, IV) for 12 weeks as induction therapy. Patients who undergo surgical resection will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for up to 13 cycles. Patients who receive definitive concurrent chemoradiotherapy will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for a maximum duration of 1 year.	Drug	Sacituzumab tirumotecan (SKB264) in combination with toripalimab

Primary outcome

18m EFS rate
Time frame: Time from the first dose treatment to 18 months
18-month progression-free survival (PFS) rate
Surgical Conversion Rate
Time frame: From enrollment until 8 weeks after completion of induction therapy
The Surgical Resection Rate is defined as the proportion of subjects who successfully undergo surgical resection after completing the induction therapy phase

7 secondary outcomes

Event-free survival (EFS)
Time frame: Time from first subject enrollment to study completion, or up to 60 months
R0 surgical resection rate
Time frame: Time from the first subject dose to study completion, or up to 60 months
Complete Response (pCR) rate
Time frame: Time from the first subject dose to study completion, or up to 60 months
Major Pathological Response (MPR) rate
Time frame: Time from the first subject dose to study completion, or up to 60 months
Objective response rate (ORR)
Time frame: Time from the first subject dose to study completion, or up to 60 months
Adverse events (AEs)
Time frame: From the first dose to 28 days after the last dose, until 36 months
Overall survival (OS)
Time frame: Time from the first subject dose to study completion, or up to 60 months

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 3 Apr 2026.

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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.

Yongchang Zhang, MD contact

+8613873123436

zhangyongchang@csu.edu.cn

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 Sacituzumab tirumotecan plus toripalimab in people with Non Small Cell Lung Cancer (Stage III), run by Hunan Province Tumor Hospital 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 24 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 3 Apr 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 Yongchang Zhang, MD (+8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18m EFS rate (time frame: Time from the first dose treatment to 18 months). 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 NCT06706219.

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 3 Apr 2026.