OncoMatch/Clinical Trials/NCT06219317
Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
Is NCT06219317 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab for nsclc stage iv.
Treatment: Cemiplimab — This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment. Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: ALK fusion
Excluded: EGFR exon 19 mutation
Excluded: EGFR exon 21 mutation
Excluded: ROS1 fusion
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG/WHO 0–1
Prior therapy
Cannot have received: pneumonectomy
Prior pneumonectomy
Cannot have received: radiotherapy
radiotherapy (including mediastinal radiotherapy) within the last 3 years before registration
Cannot have received: chemotherapy
chemotherapy within the last 3 years before registration
Cannot have received: immune-checkpoint inhibitor
immune-check inhibitors within the last 3 years before registration
Cannot have received: targeted therapy
targeted therapy for lung cancer within the last 3 years before registration
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L
Kidney function
GFR (MDRD) ≥30 mL/min
Liver function
Serum total bilirubin ≤1.5x ULN (or ≤3x ULN, if liver metastases or Gilbert syndrome); AST/ALT ≤3x ULN (or ≤5x ULN, if liver metastases)
Hepatic function: Serum total bilirubin ≤1.5x ULN (or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome); AST and/or ALT ≤3x ULN (or ≤5x ULN, if liver metastases). Renal function: GFR based on MDRD equation ≥30 mL/min. Bone marrow function: Hemoglobin ≥9.0 g/dL; ANC ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify