OncoMatch/Clinical Trials/NCT06431633
Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.
Is NCT06431633 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Zimberelimab and Sacituzumab govitecan for lung diseases.
Treatment: Zimberelimab · Sacituzumab govitecan · Cisplatin · Carboplatin — Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. 129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment. This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles. The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (PDL1 value analysed locally (hospital must be able to provide this value before randomization))
PDL1 value analysed locally (hospital must be able to provide this value before randomization)
Excluded: ALK fusion
Patients with ALK translocation ... known mutations before inclusion in this trial.
Excluded: STK11 mutation
Patients with ... STK11 ... known mutations before inclusion in this trial.
Excluded: KEAP1 mutation
Patients with ... KEAP1 known mutations before inclusion in this trial.
Excluded: EGFR mutation
Patients with any known EGFR mutation cannot be enrolled in the study.
Disease stage
Required: Stage IB, IIA, IIB, IIIA, IIIB (N2) (8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)
Excluded: Stage T4 WITH INVASION OF HEART, GREAT VESSELS, CARINA, TRACHEA, OESOPHAGUS OR SPINE
Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — neoadjuvant
Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory.
Must have received: anti-PD-1 therapy — neoadjuvant
Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory.
Cannot have received: radiation therapy
Exception: preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.
Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.
Lab requirements
Blood counts
Adequate hematologic function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate hematologic and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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