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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) | Clinical Trials | Clareo Health

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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)

NCT07108816•Henan Cancer Hospital

View on ClinicalTrials.gov

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, 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years at the time of informed consent signing.
•2. ECOG performance status score of 0 or 1 within 7 days before administration.
•3. Non-small cell lung cancer (NSCLC) confirmed by histological or cytological analysis.
•4. Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene;
•5. Positive PD-L1 expression (tumor proportion score \[TPS\] ≥ 1%) confirmed by immunohistochemistry (IHC).
•6. 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.
•7. Patients with resectable stage II-IIIB NSCLC (according to the 8th edition of the UICC/AJCC TNM staging system) after MDT evaluation;
•8. At least one measurable lesion present, as defined by RECIST 1.1 criteria.
•9. Patients willing to receive curative-intent surgical treatment.
•10. Assessment by a surgeon confirms tumor resectability and absence of surgical contraindications.
+8 more criteria

Exclusion Criteria

•1. Histological or cytological confirmation demonstrating the presence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components within the tumor.
•2. 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.
•3. Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.
•4. 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.
•5. 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.
•6. Known history of allergy to the study drugs or their components, immunodeficiency, or organ transplantation;
•7. 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.
•8. 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).
•9. Active infections requiring systemic treatment within 2 weeks prior to the first dose administration;
•10. 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.
+5 more criteria

Key Dates

Start Date

August 15, 2025

Primary Completion Date

December 30, 2026

Completion Date

August 30, 2028

Last Updated

August 7, 2025

Enrollment

ESTIMATED participants

Conditions

Resectable Stage II-IIIB NSCLC

Interventions

Neoadjuvant Sacituzumab tirumotecan + tagitanlimab Followed by adjuvant tagitanlimab

DRUG

Contacts

Qiming Wang

CONTACT

+86 13783590691 qimingwang1006@126.com