OncoMatch/Clinical Trials/NCT06055465
Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer
Is NCT06055465 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Govitecan and Pembrolizumab for lung cancer.
Treatment: Sacituzumab Govitecan · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Required: Stage II, III, IIIB (N2) (AJCC 8th edition)
AJCC 8th edition Stage II-III based on the following diagnostic workup and tumour is considered potentially resectable * Distant metastasis staging by PET/CT whole body or CT thorax and upper abdomen with contrast * Patients with stage IIIB (N2) that is considered potentially resectable by cardiothoracic surgeon may be enrolled
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: prior anti-cancer treatment can be accepted except for drugs listed in exclusion criteria (3) to (8)
Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment Day 1
Cannot have received: PD-1 inhibitor
Any previous treatment with a PD-1 or PD-L1 or CTLA4 inhibitor, or another agent directed to stimulatory or coinhibitory T-cell receptor (OX40, CD137, etc)
Cannot have received: PD-L1 inhibitor
Any previous treatment with a PD-1 or PD-L1 or CTLA4 inhibitor, or another agent directed to stimulatory or coinhibitory T-cell receptor (OX40, CD137, etc)
Cannot have received: CTLA-4 inhibitor
Any previous treatment with a PD-1 or PD-L1 or CTLA4 inhibitor, or another agent directed to stimulatory or coinhibitory T-cell receptor (OX40, CD137, etc)
Cannot have received: topoisomerase inhibitor
Any previous treatment with sacituzumab govitecan, topoisomerase inhibitor, or TROP-2 targeted therapy.
Cannot have received: TROP2-targeted therapy (sacituzumab govitecan)
Any previous treatment with sacituzumab govitecan, topoisomerase inhibitor, or TROP-2 targeted therapy.
Cannot have received: radiation therapy
Previous radiotherapy to the chest including radiation to mediastinal tumours (e.g. germ cell tumours and thymic tumours)
Lab requirements
Blood counts
haemoglobin ≥ 9.0g/dl, absolute neutrophil count ≥ 1.5 x 10^9/l, platelet count ≥ 100 x 10^9/l
Kidney function
calculated creatinine clearance ≥ 30 ml/min, according to the formula of cockcroft-gault equation
Liver function
bilirubin ≤ 1.5 x uln, ast/alt ≤ 2.5 x uln
Cardiac function
severe or uncontrolled cardiac disease, congestive heart failure nyha class iii or iv, unstable angina pectoris, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia under medical control); history of qtc interval prolongation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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