OncoMatch/Clinical Trials/NCT06219317
Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
Is NCT06219317 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06219317 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pneumonectomy, radiotherapy, chemotherapy disqualifies patients from enrollment.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR exon 19 mutation is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualifyRelated pages