OncoMatch/Clinical Trials/NCT05493566
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
Is NCT05493566 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Aldesleukin and Pembrolizumab for lung non-small cell carcinoma.
Treatment: Aldesleukin · Pembrolizumab — This early phase 1 trial will investigate the combination of low-dose interleukin-2 (IL-2) and pembrolizumab in patients with previously untreated stage IV non-small cell lung cancer (NSCLC). Preclinical data demonstrate reinvigoration of exhausted T cells into an effector-like phenotype with improved anti-tumor activity in response to this combination. This study will evaluate T cell function as well as clinical outcomes associated with this combination therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥1% (≥1%)
Patients must have tumor PD-L1 expression of ≥1% (by 22c3 PD-L1 companion testing); patients whose PD-L1 status could not be determined are also eligible. Patients with known PD-L1 of 0% will be excluded.
Excluded: ALK any targetable driver mutation
Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc).
Excluded: EGFR exon 19 deletion
Any targetable driver mutation (e.g. ALK, EGFR exon 19 del, etc).
Disease stage
Required: Stage IV, IVA, IVB (AJCC v8)
Metastatic disease required
Stage IV non-small cell lung cancer (NSCLC), based on the 8th edition of the American Joint Committee on Cancer (AJCC) NSCLC Staging System.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Any prior chemotherapy or immunotherapy for advanced lung cancer.
Cannot have received: immunotherapy
Any prior chemotherapy or immunotherapy for advanced lung cancer.
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents.
Cannot have received: anti-PD-L1 therapy
Prior treatment with anti-PD-1 or anti-PD-L1 therapies or pathway-targeting agents.
Lab requirements
Blood counts
ANC ≥ 1,500/mcL; Platelet count ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this)
Kidney function
Creatinine Clearance > 60 mL/min
Liver function
AST/ALT ≤ 2.5 x ULN; serum bilirubin ≤ 1.5 x ULN
Patients must have adequate organ and marrow function, including: Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelet count ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this); AST/ALT ≤ 2.5 x ULN; Serum bilirubin ≤ 1.5 x ULN; Creatinine Clearance > 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University/Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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