Non-Small Cell Lung CancerPhase 2NCT07819578
Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC
A Phase 2 study testing Toripalimab and Sacituzumab Tirumotecan (SKB264) in people with Non-Small Cell Lung Cancer, run by Shaodong Hong.
Trial summary
This is a prospective, multicenter, single-arm Phase II investigator-initiated trial evaluating neoadjuvant toripalimab plus sacituzumab tirumotecan (SKB264) in treatment-naive adults with resectable or potentially resectable, driver-negative non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Toripalimab and Sacituzumab Tirumotecan (SKB264)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained before any study procedure.
- Age 18 to 75 years, male or female.
- Histologically/cytologically confirmed, treatment-naive, resectable or potentially resectable NSCLC: stage II-IIIA and selected IIIB (T3N2, T4N2) per IASLC/UICC TNM 9th edition.
- Disease staged as cTNM by PET-CT or by neck/chest/abdominal/pelvic CT plus whole-body bone scan and brain MRI.
- Multidisciplinary team including thoracic surgeon judges lesion resectable or potentially resectable.
- At least one measurable target lesion per RECIST 1.1.
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- ECOG performance status 0-1.
- Adequate organ function (baseline, no transfusion, rh-EPO, or G-CSF within 2 weeks before first dose): neutrophils ≥1.5 ×10^9/L; platelets ≥100 ×10^9/L; hemoglobin ≥9 g/dL.
- AST, ALT, ALP ≤2.5 × ULN; TBil ≤1.5 × ULN.
- For liver metastases: AST/ALT ≤5 × ULN; TBil ≤2 × ULN.
- For liver or bone metastases: ALP ≤5 × ULN.
- Creatinine clearance (Cockcroft-Gault) ≥60 mL/min.
- INR, APTT, PT ≤1.5 × ULN.
- TSH within normal range; if TSH abnormal but T3 and free T4 normal, eligible.
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and use effective contraception during treatment and until 12 months after last dose; men with partners of childbearing potential must use effective contraception during treatment and until 12 months after last dose.
Who cannot join
- Neuroendocrine histology component in tumor pathology.
- Known EGFR sensitizing mutation or ALK fusion (for non-squamous NSCLC, EGFR/ALK status must be determined).
- Other malignancy within 5 years, except those with clinically negligible metastatic risk and curative treatment intent (e.g., adequately treated carcinoma in situ as per protocol examples).
- Severe or uncontrolled comorbidities, including symptomatic cerebrovascular events or liver disease at Child-Pugh grade ≥A.
- History of allogeneic stem cell transplantation or solid organ transplantation.
- Severe dry eye syndrome, severe meibomian gland dysfunction, severe blepharitis, or corneal disorders that may delay corneal healing.
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- History of interstitial lung disease requiring steroids, or active ILD.
- HIV positive or diagnosed AIDS.
- Active tuberculosis.
- Uncontrolled active HBV infection (HBsAg positive with HBV-DNA above local upper limit of normal). HBV-DNA must be <500 IU/mL within 28 days before randomization/inclusion.
- Active HCV infection (HCV antibody positive and HCV RNA positive).
- Known hypersensitivity to toripalimab or sacituzumab tirumotecan (or excipients).
- Live vaccine within 30 days before first dose (except inactivated vaccines allowed where specified by protocol, including local policy).
- Any systemic or local anticancer treatment before first study treatment.
- Use of traditional Chinese medicines with anticancer indication within 7 days before first dose, or need to continue such drugs during study.
- Other investigational drug not discontinued for at least 5 half-lives or 2 months (whichever is longer) before first dose.
- Any known or suspected autoimmune disease or immunodeficiency, except primary hypothyroidism (stable, not requiring hormones, or stable on physiologic hormone replacement) and stable type 1 diabetes mellitus with controlled blood glucose.
- Medical or psychiatric conditions likely to cause premature discontinuation or compromise safety, sampling, or follow-up, including severe social or compliance risks.
- Pregnancy or breastfeeding; unwillingness to use effective contraception as specified.
- Any other condition considered unsuitable by investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study of Toripalimab Combined With Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer
This is a prospective, multicenter, single-arm Phase II investigator-initiated trial evaluating neoadjuvant toripalimab plus sacituzumab tirumotecan (SKB264) in treatment-naive adults with resectable or potentially resectable, driver-negative non-small cell lung cancer (NSCLC). Eligible participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2) and will receive sacituzumab tirumotecan 5 mg/kg plus toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles. Participants deemed operable after multidisciplinary assessment will undergo definitive surgery. The primary endpoint is pathologic complete response. A Simon two-stage minimax design plans to enroll 30 participants.
Read the detailed description
This prospective, multicenter, single-arm Phase II investigator-initiated trial evaluates neoadjuvant sacituzumab tirumotecan (SKB264), a TROP2-directed antibody-drug conjugate, plus the PD-1 antibody toripalimab in treatment-naive adults with resectable or potentially resectable, driver-negative NSCLC. Participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2). Sacituzumab tirumotecan 5 mg/kg and toripalimab 3 mg/kg are administered intravenously on Day 1 every 2 weeks for up to 6 cycles. Surgery is planned 4-6 weeks after the final neoadjuvant dose when the participant remains operable following multidisciplinary assessment. Tumor response is assessed using RECIST 1.1. Safety is assessed using NCI CTCAE version 5.0, including adverse events, serious adverse events, perioperative complications, and surgery delays or cancellations. The primary endpoint is pathologic complete response, defined as no residual viable tumor cells in the resected primary tumor and all resected lymph nodes. Major pathologic response is defined as residual viable tumor of 10% or less.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Toripalimab, Sacituzumab Tirumotecan (SKB264)
- Keywords
- Toripalimab, Sacituzumab Tirumotecan, NSCLC, Resectable NSCLC, Neoadjuvant Therapy
- 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.
ToripalimabDrug
Toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with sacituzumab tirumotecan.
Sacituzumab Tirumotecan (SKB264)Drug
Sacituzumab tirumotecan (SKB264) 5 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with toripalimab.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab plus sacituzumab tirumotecan | Experimental | Participants will receive sacituzumab tirumotecan 5 mg/kg intravenously on Day 1 every 2 weeks combined with toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy. Surgery will be performed after multidisciplinary assessment when appropriate. Postoperative or adjuvant treatment will be determined according to guidelines and investigator assessment. Receives: Drug: Toripalimab; Drug: Sacituzumab Tirumotecan (SKB264) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Proportion of participants with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes. Participants without surgery or evaluable surgical pathology will be counted as non-pCR.
Measured: At definitive surgery, up to 18 weeks after first study treatment
Secondary outcomes (7)
Major Pathological Response (MPR) Rate
Proportion of participants with residual viable tumor of 10% or less in the resected primary tumor and all resected lymph nodes.
Measured: At definitive surgery, up to 18 weeks after first study treatment
R0 Resection Rate
Proportion of participants who undergo R0 resection, defined as microscopically margin-negative resection, after neoadjuvant therapy.
Measured: At definitive surgery, up to 18 weeks after first study treatment
Pathological Downstaging Rate
Proportion of participants with pathological stage lower than baseline clinical stage at definitive surgery.
Measured: At definitive surgery, up to 18 weeks after first study treatment
Objective Response Rate (ORR)
Proportion of participants with complete response or partial response according to investigator-assessed RECIST 1.1 after neoadjuvant therapy.
Measured: Up to 18 weeks after first study treatment
Event-Free Survival (EFS)
Time from enrollment to disease progression precluding surgery, disease progression or recurrence after surgery, disease progression in participants who do not undergo surgery, or death from any cause, whichever occurs first.
Measured: Up to 60 months from enrollment
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: Up to 60 months from enrollment
Incidence of Adverse Events
Incidence of adverse events graded according to NCI CTCAE version 5.0.
Measured: From first study treatment through 90 days after the last study treatment or surgery, whichever occurs later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (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 CancerStudies 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
- Model description
- Neoadjuvant toripalimab plus sacituzumab tirumotecan for resectable driver-negative NSCLC.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaodong Hong
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor-investigator, Shaodong Hong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819578
- Sponsor's protocol ID
- 2026-FXY-019-NEIKE
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data and data dictionaries from this investigator-initiated Phase II oncology study will not be shared at this time due to current sponsor/institutional policy, data governance requirements, and pending legal/ethics arrangements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Toripalimab Combined With Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07819578
- Acronym / sponsor ID
- 2026-FXY-019-NEIKE
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Toripalimab, Sacituzumab Tirumotecan, NSCLC, Resectable NSCLC, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shaodong HongUniversity, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Sep 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 is a prospective, multicenter, single-arm Phase II investigator-initiated trial evaluating neoadjuvant toripalimab plus sacituzumab tirumotecan (SKB264) in treatment-naive adults with resectable or potentially resectable, driver-negative non-small cell lung cancer (NSCLC). Eligible participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2) and will receive sacituzumab tirumotecan 5 mg/kg plus toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles. Participants deemed operable after multidisciplinary assessment will undergo definitive surgery. The primary endpoint is pathologic complete response. A Simon two-stage minimax design plans to enroll 30 participants.
Detailed description
This prospective, multicenter, single-arm Phase II investigator-initiated trial evaluates neoadjuvant sacituzumab tirumotecan (SKB264), a TROP2-directed antibody-drug conjugate, plus the PD-1 antibody toripalimab in treatment-naive adults with resectable or potentially resectable, driver-negative NSCLC. Participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2). Sacituzumab tirumotecan 5 mg/kg and toripalimab 3 mg/kg are administered intravenously on Day 1 every 2 weeks for up to 6 cycles. Surgery is planned 4-6 weeks after the final neoadjuvant dose when the participant remains operable following multidisciplinary assessment. Tumor response is assessed using RECIST 1.1. Safety is assessed using NCI CTCAE version 5.0, including adverse events, serious adverse events, perioperative complications, and surgery delays or cancellations. The primary endpoint is pathologic complete response, defined as no residual viable tumor cells in the resected primary tumor and all resected lymph nodes. Major pathologic response is defined as residual viable tumor of 10% or less.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Neoadjuvant toripalimab plus sacituzumab tirumotecan for resectable driver-negative NSCLC.
| Arm | Type | Receives |
|---|---|---|
| Toripalimab plus sacituzumab tirumotecan | Experimental | Drug: Toripalimab, Drug: Sacituzumab Tirumotecan (SKB264)Participants will receive sacituzumab tirumotecan 5 mg/kg intravenously on Day 1 every 2 weeks combined with toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy. Surgery will be performed after multidisciplinary assessment when appropriate. Postoperative or adjuvant treatment will be determined according to guidelines and investigator assessment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed informed consent obtained before any study procedure.
- Age 18 to 75 years, male or female.
- Histologically/cytologically confirmed, treatment-naive, resectable or potentially resectable NSCLC: stage II-IIIA and selected IIIB (T3N2, T4N2) per IASLC/UICC TNM 9th edition.
- Disease staged as cTNM by PET-CT or by neck/chest/abdominal/pelvic CT plus whole-body bone scan and brain MRI.
- Multidisciplinary team including thoracic surgeon judges lesion resectable or potentially resectable.
Key exclusion criteria (20 listed)
- Neuroendocrine histology component in tumor pathology.
- Known EGFR sensitizing mutation or ALK fusion (for non-squamous NSCLC, EGFR/ALK status must be determined).
- Other malignancy within 5 years, except those with clinically negligible metastatic risk and curative treatment intent (e.g., adequately treated carcinoma in situ as per protocol examples).
- Severe or uncontrolled comorbidities, including symptomatic cerebrovascular events or liver disease at Child-Pugh grade ≥A.
- History of allogeneic stem cell transplantation or solid organ transplantation.
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 |
|---|---|---|
| ToripalimabToripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with sacituzumab tirumotecan. | Drug | Toripalimab plus sacituzumab tirumotecan |
| Sacituzumab Tirumotecan (SKB264)Sacituzumab tirumotecan (SKB264) 5 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with toripalimab. | Drug | Toripalimab plus sacituzumab tirumotecan |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At definitive surgery, up to 18 weeks after first study treatment
Proportion of participants with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes. Participants without surgery or evaluable surgical pathology will be counted as non-pCR.
7 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: At definitive surgery, up to 18 weeks after first study treatment
R0 Resection Rate
Time frame: At definitive surgery, up to 18 weeks after first study treatment
Pathological Downstaging Rate
Time frame: At definitive surgery, up to 18 weeks after first study treatment
Objective Response Rate (ORR)
Time frame: Up to 18 weeks after first study treatment
Event-Free Survival (EFS)
Time frame: Up to 60 months from enrollment
Overall Survival (OS)
Time frame: Up to 60 months from enrollment
Incidence of Adverse Events
Time frame: From first study treatment through 90 days after the last study treatment or surgery, whichever occurs later
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 15 Sep 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data and data dictionaries from this investigator-initiated Phase II oncology study will not be shared at this time due to current sponsor/institutional policy, data governance requirements, and pending legal/ethics arrangements.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab and Sacituzumab Tirumotecan (SKB264) in people with Non-Small Cell Lung Cancer, run by Shaodong Hong.
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 15 inclusion and 20 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 Sep 2026. 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 Shaodong Hong Hong, M.D., Ph.D. (+8615920527656, hongshd@sysucc.org.cn), 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: At definitive surgery, up to 18 weeks after first study treatment). 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 15 Sep 2026.