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Resectable Stage II-IIIB NSCLCPhase 2NCT07108816

A Single-center, Phase II Clinical Trial Evaluating the Efficacy of Sacituzumab Tirumotecan in Combination With Tagitanlimab as Neoadjuvant Therapy for PD-L1-positive, Resectable Stage II to IIIB Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab in people with Resectable Stage II-IIIB NSCLC, run by Henan Cancer Hospital.

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

In recent years, substantial progress has been made in the development of perioperative immunotherapy for non-small cell lung cancer (NSCLC). Accumulating evidence indicates that both neoadjuvant and adjuvant immunotherapy can significantly enhance key clinical endpoints, including pathological response rate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Stage II-IIIB NSCLC
What is being tested?
Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
15 Aug 2025to 30 Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of informed consent signing.
  • ECOG performance status score of 0 or 1 within 7 days before administration.
  • Non-small cell lung cancer (NSCLC) confirmed by histological or cytological analysis.
  • Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;
  • Positive PD-L1 expression (tumor proportion score [TPS] ≥ 1%) confirmed by immunohistochemistry (IHC).
  • No prior local treatment (e.g., surgery or radiotherapy) for non-small cell lung cancer (NSCLC) and no history of systemic anti-tumor therapy, including cytotoxic therapy, targeted therapy (such as tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine-based treatments, or any other investigational drug therapies.
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  • Patients with resectable stage II-IIIB NSCLC (according to the 8th edition of the UICC/AJCC TNM staging system) after MDT evaluation;
  • At least one measurable lesion present, as defined by RECIST 1.1 criteria.
  • Patients willing to receive curative-intent surgical treatment.
  • Assessment by a surgeon confirms tumor resectability and absence of surgical contraindications.
  • Adequate organ and bone marrow function(with no receipt of blood transfusions, recombinant human thrombopoietin, or colony-stimulating factors within two weeks prior to first drug administration), defined as follows:
  • Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin ≥ 90g/L.
  • Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 times ULN;
  • Renal function: Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
  • International Normalized Ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) values are ≤ 1.5 times the upper limit of normal (ULN).
  • Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
  • For female subjects of childbearing potential and male subjects with reproductive potential, a commitment to effective medical contraception is required from the date of informed consent signing through 6 months after the last dose administration.
  • The subjects voluntarily joined this study, signed the informed consent form, and were able to comply with the visit and related procedures as stipulated in the protocol.

Who cannot join

  • Histological or cytological confirmation demonstrating the presence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components within the tumor.
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other agent specifically targeting T-cell co-stimulatory or checkpoint pathways.
  • Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.
  • Subjects requiring the use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to first dosing and throughout the study period are excluded (the use of strong CYP3A4 inhibitors or inducers is prohibited in this study; a list of representative CYP3A4 inhibitors and inducers can be found in Appendix 6). All subjects must avoid concomitant administration of any known drugs, herbal supplements, and/or dietary items that may induce CYP3A4 activity.
  • A history of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
  • Known history of allergy to the study drugs or their components, immunodeficiency, or organ transplantation;
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  • A history of interstitial lung disease (ILD) or non-infectious pneumonia requiring corticosteroid therapy, or current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia at screening that cannot be ruled out by imaging; clinically significant pulmonary impairment due to concurrent lung conditions, including but not limited to underlying pulmonary disorders (e.g., pulmonary embolism within 3 months prior to study entry, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion), autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.
  • Active autoimmune diseases requiring systemic therapy within the past two years (hormone replacement therapy is excluded from systemic treatment, including conditions such as type 1 diabetes, hypothyroidism managed with thyroid hormone replacement alone, and adrenal or pituitary insufficiency treated solely with physiological doses of glucocorticoid replacement therapy).
  • Active infections requiring systemic treatment within 2 weeks prior to the first dose administration;
  • Active hepatitis B [positive hepatitis B surface antigen (HBsAg), with HBV-DNA testing required; HBV-DNA ≥ 500 IU/mL or above the lower limit of quantification (whichever is higher)] or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection). Note: Subjects who are HBsAg-positive must receive anti-hepatitis B virus therapy during the study treatment period.
  • Positive serology for human immunodeficiency virus (HIV) or a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection;
  • Concomitant diseases that, in the investigator's judgment, pose a significant risk to patient safety or may interfere with study completion, including but not limited to medication-uncontrolled hypertension, severe diabetes, or active infections.
  • A documented history of severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or corneal disorders associated with delayed corneal healing;
  • Pregnant or breastfeeding women;
  • Any condition that may interfere with the assessment of the investigational drug, compromise subject safety, or affect the interpretation of study results, as well as any other condition that the investigator considers unsuitable for participation in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qiming Wang contact

+86 13783590691

qimingwang1006@126.com

About this study

In recent years, substantial progress has been made in the development of perioperative immunotherapy for non-small cell lung cancer (NSCLC). Accumulating evidence indicates that both neoadjuvant and adjuvant immunotherapy can significantly enhance key clinical endpoints, including pathological response rate, event-free survival (EFS), and disease-free survival (DFS), particularly in patients with stage II-III NSCLC. However, in the subset of patients with resectable stage II-IIIB NSCLC, the pathological complete response (pCR) rate following neoadjuvant immunotherapy remains modest at approximately 17-25%, underscoring the need for more effective therapeutic strategies and novel combination regimens. TROP2-targeted antibody-drug conjugates (TROP2-ADCs) have demonstrated promising antitumor activity and a manageable safety profile in patients with previously treated advanced NSCLC. Furthermore, the combination of Sacituzumab tirumotecan and tagitanlimab has shown robust efficacy in the first-line treatment of PD-L1-positive (tumor proportion score [TPS] ≥ 1%), driver gene-negative advanced NSCLC, with an objective response rate (ORR) exceeding 80%. Based on these encouraging data, we designed this study to evaluate the efficacy and safety of Sacituzumab tirumotecan in combination with tagitanlimab as neoadjuvant therapy in patients with PD-L1-positive (TPS ≥ 1%), resectable stage II-IIIB NSCLC.

Being tested
Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimabDrug

    Patients will receive 4 cycles of neoadjuvant treatment with preoperative Sacituzumab tirumotecan in combination with tagitanlimab, followed by surgery.

    After surgery, patients will receive up to 13 cycles of adjuvant tagitanlimab.

Study groups in NCT07108816
Study groupRoleWhat they receive
Perioperative immunotherapy groupExperimentalNeoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab
Receives: Drug: Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab

What is being measured

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

  1. Pathological Complete Response

    0% residual viable tumor cells in the primary tumor and sampled lymph nodes

    Measured: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy

Secondary outcomes (6)

  1. Major Pathological Response

    Major Pathological Response (≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes)

    Measured: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy

  2. R0 Resection Rate

    The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.

    Measured: Pre-operation

  3. Objective Response Rate (ORR)

    Defined as the proportion of patients whose tumor size shrinks to predefined values，which including cases of CR and PR. Objective tumor response will be assessed using RECIST 1.1. Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1.

    Measured: 1 month after surgery

  4. Event-free survival(EFS)

    Defined as the time from treatment initiation to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause, assessed according to RECIST v1.1.

    Measured: Up to 24 months

  5. Overall survival (OS)

    Defined as the time from the initiation of study protocol treatment to the subject's death from any cause.

    Measured: Up to 5 years

  6. Adverse Events (AEs)

    The number of participants experiencing an AE will be assessed

    Measured: From date of treatment allocation until surgery or within 30 days after last dose of preoperative treatment

Timeline

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

  1. First posted7 Aug 2025
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Resources

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
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108816
Sponsor's protocol ID
2025-277
Status last verified
Jul 2025
First submitted
31 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab in people with Resectable Stage II-IIIB NSCLC, run by Henan Cancer 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 18 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 7 Aug 2025. 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 Qiming Wang (+86 13783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (time frame: Assessment of postoperative pathology within 6 weeks of neoadjuvant therapy). 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 NCT07108816.

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 7 Aug 2025.

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