NSCLC (Non-small Cell Lung Cancer)Phase 2TianjinCIHNCT07438600
Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC
A Phase 2 study testing Sacituzumab Govitecan (SG)+Toripalimab in people with NSCLC (Non-small Cell Lung Cancer), run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- Sacituzumab Govitecan (SG)+Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2026to 28 Feb 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
- Age ≥18 years at the time of informed consent signing, either sex;
- ECOG performance status score of 0-1 within 7 days prior to dosing;
- Histologically or cytologically confirmed NSCLC;
- Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;
- No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic antineoplastic therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, traditional Chinese medicine therapy, and any other investigational drug therapy;
- Patients with resectable stage II-IIIB NSCLC as assessed by MDT (according to UICC/AJCC 8th edition TNM staging);
Show all 17Show fewer
- At least one measurable lesion (according to RECIST 1.1 criteria);
- Patients who agree to undergo radical surgical treatment;
- Surgical evaluation confirms operability with no contraindications to surgery;
- Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to first dosing), defined as follows:
- Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹/L; Platelets (PLT) ≥ 100×10⁹/L; Hemoglobin ≥ 90 g/dL;
- Hepatic function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) ≤ 2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5×ULN;
- Renal function: Creatinine clearance (Ccr) ≥ 60 ml/min (Cockcroft-Gault formula, see Appendix);
- Coagulation function: International normalized ratio (INR), Activated partial thromboplastin time (APTT), and Prothrombin time (PT) ≤ 1.5×ULN;
- Cardiac function: Echocardiography (ECHO) or Multiple gated acquisition (MUGA) scan showing left ventricular ejection fraction (LVEF) ≥ 50%;
- For female subjects of childbearing potential and male subjects with partners of childbearing potential, must agree to use effective medical contraception from the time of informed consent signing until 6 months after the last dose (see Appendix 2 for details);
- Subjects voluntarily participate in this study, sign informed consent, and are able to comply with protocol-specified visits and related procedures.
Who cannot join
- Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways;
- Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors;
- Requirement for strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to first dosing and during the study (strong CYP3A4 inhibitors or inducers are not permitted in this study; Appendix 6 lists representative drugs of strong CYP3A4 inhibitors or inducers); all subjects must avoid concomitant use of any drugs, herbal supplements, and/or foods known to induce CYP3A4.
- Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;
- Known history of hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;
Show all 15Show fewer
- History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment (non-infectious), current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;
- Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement therapy);
- Active infection requiring systemic treatment within 2 weeks prior to first dosing;
- Active hepatitis B [hepatitis B surface antigen (HBsAg) positive, HBV-DNA testing required; HBV-DNA ≥ 500 IU/mL or above the lower limit of detection, whichever is higher] or hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection). Note: For HBsAg-positive subjects, anti-hepatitis B virus treatment is required during study treatment;
- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
- Severe concomitant diseases that endanger patient safety or affect study completion, as judged by the investigator, including but not limited to uncontrolled hypertension with medication, severe diabetes, active infection, etc.;
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that prevents delayed corneal healing;
- Pregnant or lactating women;
- Any condition that interferes with the evaluation of study drugs, subject safety, or interpretation of study results, or any other condition deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dongsheng Yue Tianjin Medical University Cancer Institute and Hospital contact
About this study
Official title: A Single-center, Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- Sacituzumab Govitecan (SG)+Toripalimab
- Keywords
- NSCLC
- 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 Govitecan (SG)+ToripalimabDrug
- Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle.
- Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy group | Experimental | 1. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle.
2. Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle. Receives: Drug: Sacituzumab Govitecan (SG)+Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatmen
Secondary outcomes (7)
Overall Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 before surgery.
Measured: Up to Study Week 15 (before surgery)
Radiological downstaging rate
The proportion of patients with radiological T, N, and overall stage reduction (AJCC v9) compared to baseline after neoadjuvant therapy.
Measured: Up to Study Week 15 (before surgery)
Major Pathological Response (mPR) Rate
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment
Event Free Survival (EFS)
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from randomization until death from any cause.
Measured: Up to approximately 2 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)
An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. The number of participants who experienced an AE is presented.
Measured: Up to approximately 2 years
Change From Baseline in Neoadjuvant and Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items.
Measured: Baseline, during the neoadjuvant phase (Cycle 3), during the adjuvant phase (Cycles 1, 3, 5, and 7), and during safety follow-up visits (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start24 Feb 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438600
- Sponsor's protocol ID
- SKB264-NSIP-015
- Acronym
- TianjinCIH
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 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
- A Single-center, Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Toripalimab as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC
- ClinicalTrials.gov ID
- NCT07438600
- Acronym / sponsor ID
- TianjinCIH / SKB264-NSIP-015
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 27 Feb 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, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of neoadjuvant therapy of sacituzumab tirumotecan combined with toripalimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy group | Experimental | Drug: Sacituzumab Govitecan (SG)+Toripalimab1. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle. 2. Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years at the time of informed consent signing, either sex;
- ECOG performance status score of 0-1 within 7 days prior to dosing;
- Histologically or cytologically confirmed NSCLC;
- Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;
- No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic antineoplastic therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, traditional Chinese medicine therapy, and any other investigational drug therapy;
Key exclusion criteria (15 listed)
- Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways;
- Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors;
- Requirement for strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to first dosing and during the study (strong CYP3A4 inhibitors or inducers are not permitted in this study; Appendix 6 lists representative drugs of strong CYP3A4 inhibitors or inducers); all subjects must avoid concomitant use of any drugs, herbal supplements, and/or foods known to induce CYP3A4.
- Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;
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 Govitecan (SG)+Toripalimab1. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, on Day 1 of each cycle. 2. Toripalimab will be administered at a dose of 240 mg via intravenous infusion, with a treatment cycle of every 3 weeks, on Day 1 of each cycle. | Drug | Neoadjuvant therapy group |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatmen
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
7 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to Study Week 15 (before surgery)
Radiological downstaging rate
Time frame: Up to Study Week 15 (before surgery)
Major Pathological Response (mPR) Rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Event Free Survival (EFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 2 years
Change From Baseline in Neoadjuvant and Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Baseline, during the neoadjuvant phase (Cycle 3), during the adjuvant phase (Cycles 1, 3, 5, and 7), and during safety follow-up visits (up to 2 years)
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
Related trials for NSCLC (Non-small Cell Lung Cancer)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Dongsheng Yue Tianjin Medical University Cancer Institute and Hospital contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan (SG)+Toripalimab in people with NSCLC (Non-small Cell Lung Cancer), run by Tianjin Medical University Cancer Institute and Hospital.
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 17 inclusion and 15 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.
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 Dongsheng Yue (+8602223109106, yuedongsheng_cg@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: Up to approximately 8 weeks following completion of neoadjuvant treatmen). 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.