Actively Recruiting
Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer
Led by Chinese University of Hong Kong · Updated on 2025-05-15
37
Participants Needed
4
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The combination of neoadjuvant immunotherapy plus chemotherapy has recently been shown to improve survival outcome compared to chemotherapy alone and was recently approved for resectable non-small cell lung cancer (NSCLC). Despite so, recurrence risk of NSCLC after surgical resection remains high. Sacituzumab govitecan, a novel antibody drug conjugate, was demonstrated to be clinically active in metastatic NSCLC. This study aims to study the clinical efficacy of sacituzumab govitecan plus immunotherapy in resectable NSCLC. This is a open-label, single arm, multicentre, phase II study. Patients with EGFR/ALK negative, stage II-III (AJCC 8th edition), resectable NSCLC are eligible and will receive 4 cycles of neoadjuvant pembrolizumab plus sacituzumab govitecan, followed by surgical resection of tumour, and then 13 cycles of maintenance pembrolizumab.
CONDITIONS
Official Title
Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older able to understand and provide written informed consent
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Tumor tested negative for EGFR and ALK mutations
- Measurable disease by CT scan according to RECIST 1.1 criteria
- Tumor tissue available for research (histology preferred, cytology allowed)
- AJCC 8th edition stage II-III NSCLC considered potentially resectable
- Patients with stage IIIB (N2) may be included if deemed resectable by surgeon
- ECOG performance status of 0 or 1
- Adequate blood counts without recent transfusions or growth factors
- Adequate liver function (bilirubin ≤ 1.5 times upper limit, AST/ALT ≤ 2.5 times upper limit)
- Adequate kidney function (creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula)
- Male patients and females of childbearing potential must agree to use specified contraception
- Patients with hepatitis B virus (HBV) infection must be on antiviral therapy and well controlled
- Patients with hepatitis C virus (HCV) infection must have been treated and have undetectable viral load
- Willing and able to comply with study requirements and restrictions
You will not qualify if you...
- Presence of any distant metastasis
- Previous or current cancer within 5 years except treated localized non-melanoma skin cancer or cervical carcinoma in situ
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks before study treatment
- Mixed small cell lung cancer (SCLC) and NSCLC histology
- Prior treatment with PD-1, PD-L1, CTLA4 inhibitors or other T-cell receptor targeted agents
- Prior treatment with sacituzumab govitecan, topoisomerase inhibitors, or TROP-2 targeted therapy
- Previous chest radiotherapy including mediastinal radiation
- Positive pregnancy test or breastfeeding
- Known allergy to pembrolizumab or sacituzumab govitecan or their components
- Requirement for prohibited medications or corticosteroids contraindicated as premedication
- Concurrent treatment with other experimental or anticancer drugs within 30 days before registration
- Active chronic inflammatory bowel disease or recent gastrointestinal perforation
- Recent use of immunosuppressive medications except specified corticosteroids
- Severe or uncontrolled heart disease or serious arrhythmias
- Severe pulmonary problems or prior pneumonectomy
- Active autoimmune diseases requiring recent systemic treatment
- Active hepatitis B or C infection
- Known HIV infection
- History of primary immunodeficiency or organ transplant
- Receipt of live vaccines during trial or 30 days after last dose
- Use of drugs contraindicated with study treatments
- Any serious medical or psychological conditions that interfere with study participation
- Refusal of surgical treatment for lung cancer
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
2
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong, Hong Kong
Actively Recruiting
3
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, Hong Kong
Actively Recruiting
4
Department of Oncology, Princess Margaret Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
M
Molly SC LI, MBBS, MRCP
CONTACT
S
Sylvia CHAN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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